NEDMDG welcomes listings of job openings in relevant areas -- drug metabolism, pharmacokinetics, ADME studies etc. Please send submissions to webmaster@nedmdg.org
Summary:
We are seeking a Scientist for the Bioassay Group within our client's Analytical Biochemistry Department. The successful candidate will carry out development, qualification and validation/transfer of cell-based bioassays for biological characterization and testing of biopharmaceutical products, such as humanized monoclonal antibodies and recombinant proteins. She/he will take a leading role in the development, optimization, and validation of a wide variety of cell-based assays, as well as identification and evaluation of new technologies. The candidate will also be expected to be familiar with SOP, GLP and GMP requirements. She/he will identify, evaluate and optimize new cutting-edge technologies for improving efficiency of in-process, release, and characterization bioactivity testing. She/he will also contribute to the creation and review of documents such as development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications.
Position and core responsibilities:
The successful candidate will be expected to make detailed observations, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experiments in an independent manner. The candidate must have excellent written and oral communication skills, good time management and organizational skills, and previous supervisory experience. He/she will need to be able to solve technical problems using an experimental approach (DOE) and develop new characterization methods. The candidate will present and discuss experimental results at group/project team meetings and scientific conferences. Finally, he/she must be able to work in a team structure and interface with different research and development departments.
Essential skills and experience:
- Candidate must have expertise and thorough understanding of cell-based assay technologies and their application in the characterization for biologics, such as assays used for ADCC, CDC, cellular signaling, phosphorylation, receptor binding, cytokine secretion, cellular migration, proliferation and apoptosis
- Molecular biology expertise in reporter gene technology is a must
- Experience with FACS, AlphaScreen, HTRF, BIAcore, MSD and automation is a plus
Education:
Ph.D. with 0 to 7 years of relevant experience, preferably working with cell-based bioassay in a GLP/GMP industrial environment.
Must have hands-on experience in bioanalytical sample analysis using HPLC, LC/MS/MS and metabolite isolation/identification
If you have an interest in this or other opportunities, please send your resume as a MS Word compatible file attached to email to the attention of Basirah at RS&A. All correspondence is held in strict confidence.
(Ms) Basirah Al'Basit/Ann Rathbun
RS&A Scientific Search
Sedona, AZ 86341 USA
TEL: (928) 203-0074
EM: RSA@sedona.net
Summary:
Research Scientist ADME to perform in vitro and in vivo metabolism studies, isolate/identify metabolites by LC/MS, conduct quantitative analysis of drugs and metabolites in biological matrices and non-clinical PK analysis in support of the company’s drug discovery and development efforts.
Duties and Responsibilities:
- Conduct in vitro metabolism studies (including in vitro metabolic stability, P450 inhibition, reaction phenotyping, metabolite identification/isolation) for discovery and development drugs.
- Assay development and quantitative analyses of drug and metabolites in various biological matrices.
- Develop methods and analyze biological samples from radiolabeled preclinical/clinical studies for mass balance, metabolite profiling and metabolite ID.
- Organize experimental data, interpret and present study results to management in a timely fashion.
- Write study reports
Requirements:
- B.S or M.S in Bioanalytical sciences, Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 3-5 years of industry and/or related ADME/PK experience
- Must have hands-on experience in bioanalytical sample analysis using HPLC, LC/MS/MS and metabolite isolation/identification
- Must have experience conducting in vitro and in vivo metabolism studies.
- Good knowledge of drug metabolism, pharmacokinetic principles, PK analysis
- Experience working with radiolabeled drugs preferred but not a requisite.
- Excellent written and oral communication skills.
To apply, please use this URL.
Summary:
Research Scientist ADME to perform in vitro and in vivo metabolism studies, isolate/identify metabolites by LC/MS, conduct quantitative analysis of drugs and metabolites in biological matrices and non-clinical PK analysis in support of the company’s drug discovery and development efforts.
Duties and Responsibilities:
- Conduct in vitro metabolism studies (including in vitro metabolic stability, P450 inhibition, reaction phenotyping, metabolite identification/isolation) for discovery and development drugs.
- Assay development and quantitative analyses of drug and metabolites in various biological matrices.
- Develop methods and analyze biological samples from radiolabeled preclinical/clinical studies for mass balance, metabolite profiling and metabolite ID.
- Organize experimental data, interpret and present study results to management in a timely fashion.
- Write study reports
Requirements:
- B.S or M.S in Bioanalytical sciences, Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 5-8 years of industry and/or related ADME/PK experience
- Must have hands-on experience in bioanalytical sample analysis using HPLC, LC/MS/MS and metabolite isolation/identification
- Must have experience conducting in vitro and in vivo metabolism studies.
- Good knowledge of drug metabolism, pharmacokinetic principles, PK analysis
- Experience working with radiolabeled drugs preferred but not a requisite.
- Excellent written and oral communication skills.
To apply, please use this URL.
This person will be responsible for conducting in-vitro and in-vivo studies addressing issues related to metabolism in both discovery and development programs. Further, this person will carry out strategies for ensuring that molecules are optimized with respect to biotransformation properties before molecules are transitioned into development, and for determining the metabolic fate of molecules during preclinical and clinical development. The incumbent is also responsible for generating and monitoring technologies within the DMPK department to keep abreast of new scientific developments. The incumbent will represent DMPK on cross-functional discovery and development project teams. The position reports to the Director of Biotransformation.
Provide biotransformation expertise for small molecule discovery and development programs.
Equip laboratories and build new technologies to continually advance the science in biotransformation.
Provide timely presentations, reports and documents for world-wide regulatory registrations; respond to regulatory inquiries.
Design and carry out laboratory experiments to determine the biotransformation of small molecules in discovery and development.
Carry out radio labeled ADME and metabolism studies in house and at CRO.
Participate on multi-discipline team to provide biotransformation input and expertise.
This position reports to Chandra Prakash.
6-10 years in the pharmaceuticalindustry performing in vitro and in vivo biotransformation studies.
Experience with use of radiolabeled and cold methodology for interspecies comparative metabolite profiling.
Experienced at performing mass spec and NMR experimcnets to deduce metabolite structures.
Experience in writing reports on biotransformation work for world wide regulatory agency filings.
To apply, please use this URL.
About BiogenIdec
Essential Functions:
- Develops, applies and leads the quality conduct of pharmacokinetic (PK) and pharmacodynamic (PD) studies to support product candidates, including study design, data analysis, interpretation, and report writing.
- Follows procedures according to established SOPs and other department guidelines.
- Advises and implements PK and PD aspects of regulatory strategy for drug filings.
- Presents work at professional meetings.
- Sets goals, priorities, and timeframes.
- Interacts with interdepartmental teams to ensure that study goals and data are appropriately captured within protocols and reports.
- Effectively integrates practical and theoretical considerations to solve problems and move projects forward. Uses literature and colleagues as resources in order to solve problems.
- Is able to develop and test hypotheses, develop conclusions, and state interpretations and opinions aiding decision making.
Secondary Functions:
- Acts as representative on interdepartmental project teams.
- Assists in evaluating external commercial or academic licensing opportunities.
- Assists in developing program strategies.
- Interacts with interdepartmental groups for goal setting and budget processes.
- Other duties as assigned by supervisor.
Job Demands:
- Ability to design experiments, analyze and interpret scientific PK and PD data.
- Good communication skills – regular effective collegial communication both face-to-face and electronic as well as effective reporting.
- Excellent organizational skills.
- Excellent interpersonal skills.
Required Technical Skills:
- In-depth conceptual and technical/development expertise in the scientific area.
- Familiarity with regulatory requirements and ability to manage and implement regulatory strategy for drug filings.
Required Interpersonal Skills:
- Established team player with demonstrated ability to productively collaborate with other groups.
- Communication: maturely expresses views and opinions; listens; accepts conflicting points of view.
- Organization and planning: able to develop realistic plan for personal activities over weekly to monthly timeframe.
- Demonstrates good interactions with organizations inside/outside Biogen Idec.
Physical Requirements:
- Invests time, as required, to expedite or complete assignments which may necessitate working evening and/or weekend hours as necessary to meet business demands.
- Operates a computer.
- Is able to travel.
For Scientist II: 2-3 Years experience
For Senior Scientist: 5-7 Years experience
To apply, please use this URL.
About Biogen Idec: Transforming Discovery into Care
With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.
Learn more at www.biogenidec.com/careers.
Biogen Idec is proud to be an equal opportunity employer
Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.
Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:
Primary Role:
- This individual will provide pharmacokinetic support throughout all phases of drug development (preciinical and clinical) and be responsible for pharmacokinetic aspects of non-clinical studies, both internally and externally. This will include assessing and recommending doselregimens for molecules in clinical development by working in close partnership with Clinical, Regulatory, Process Development, and Program Management.
Metabolism / Pharmacokinetics / Modeling:
- The candidate will provide strategy and assume overall responsibility for non-clinical pharmacokinetic studies supporting the selection of drug candidates from development through commercialization. The candidate will utilize PWPD modeling, simulation, allometric scaling, and population PK skills to assess pharmacological properties of protein therapeutics and provide strategic guidance for clinical dosing regimens as well as BLAlNDA filings
Responsibilities:
- Provide leadership and oversight of non-clinical pharmacokinetics, reporting to the Head of Non-Clinical Development
- Responsible for planning and reviewing study designs, interpretation of PK.PD as well as presenting data at cross-functional teams, department meetings, and conferences
- Provide leadership in the design and implementation of the in vivo pharmacokinetics and pharmacodynamic strategies required for regulatory filings
- Provide expert level guidance in designing and interpreting pharmacokinetics studies (rodent through non-human primate) with emphasis on protein-based therapeutics
- Work collaboratively with members of team to ensure that multiple studies are completed to agreed timelines
- Serve as the primary Company representative for PK affairs related to new drug applications (US and worldwide filings; applying contemporary and innovative approaches to the design and interpretation of pharmacokinetic and toxicology studies)
- Chair a cross-functional Dose-Regimen-Toxicology team to provide dosing-regimen and toxicology program strategies for drugs in development
- Responsible for oversight of PK/Toxicology contract research organization interaction; includes GLP-level study oversight responsibilities
Education & Experience Requirements:
- PhD in Pharmacokinetics, Biochemistry, Toxicology, or related field with at least 8 - 10 years of industrial experience in the preclinical evaluation of protein and small molecule therapeutics.
Key Skills and Competencies:
- Proven leadership abilities in preclinical drug development with outstanding communication skills
- Expertise in development of dose-regimen preclinical models
- Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of GCP and regulatory guidelines is highly desirable
- Familiarity with standard modeling software (NONMEM, ADAPT II and WinNonlin) and the ability to plan, organize, and analyze PWPD data are essential
- Experience with the Amira imaging software a plus
- Proficiency designing and implementing Toxicology studies is desirable
Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.
Shire is an Equal Employment Opportunity and Affirmative Action Employer.
SciGenium is currently engaged with is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions. They are currently expanding their DMPK group, and are looking for a strong team player.
Position Deliverables:
The position of Scientist, Drug Metabolism requires an understanding of the theory and practice of in vitro and in vivo drug metabolism studies. The individual, with supervision, will primarily design and perform a variety of drug metabolism studies in support of our drug discovery and development efforts. Hands-on experience with enzyme phenotyping, metabolite structural elucidation, and CYP450 inhibition is strongly desired. Knowledge of pharmacokinetic principles is desirable as the individual may provide support as needed. The successful candidate will be responsible for applying different scientific skills including assay development and LC-MS/MS operation. The selected individual will work closely with DMPK team members to analyze and interpret data which will be presented in a multidisciplinary team environment. Qualities vital to our success include flexibility, open communication, and teamwork.
Qualifications:
- BS/MS in Analytical Chemistry, Biochemistry or related field with 5-10 years experience
- Extensive experience with a variety of drug metabolism studies, e.g. metabolic stability and metabolite profiling in microsomes, hepatocytes or biological samples from in vivo studies
- Experience in LC-MS/MS operation, method development, maintenance, and troubleshooting
- Strong interpersonal skills
- Strong oral and written communication skills
Candidates who are technically oriented, creative, organized and have excellent analytical skills are encouraged to apply. Interested candidates should forward their resumes to resume@scigenium.com , fax 208-567-3995 or send to:
SciGenium
P.O Box 380916
Cambridge, MA 02238
617-661-1067
Syndexa Pharmaceuticals is a biopharmaceutical company located at Cambridge MA, our mission is to discover and develop novel small molecule medicines for the treatment of metabolic disorders by targeting the inflammatory-metabolic signaling interface.
Responsibilities:
We are seeking a DMPK candidate with hands-on experience
- to develop and perform in vitro DMPK assays
- Technical capability to handle Chemical & Metabolic Stability, P450 isozyme identification, P450 inhibition and Plasma Protein Binding
- Characterization of small molecules physical-chemical properties
- Knowledge and experience with in vivo PK sample preparation to support drug discovery
- Experience in handling in vivo biological sample preparation and sample analysis by non GLP LC/MS-MS
Qualifications:
- Ph.D. in Drug Metabolism, Analytical Chemistry, biochemistry or related field with at least 2 years of relevant industrial experience within a DMPK function is required
- Alternatively a BS/MS level with 6+ years of experience would be considered
- Analytical or Bioanalytical skill utilizing Thermo Quantum EMR LC/MS-MS; or Preclinical Formulation experience are highly desirable
- Must be able to work independently under general supervision as well as function effectively within a team environment
Please apply online by forwarding your CV with cover letter, referencing to careers@syndexa.com
Enanta Pharmaceuticals, located in Watertown, MA, is a biopharmaceutical company engaged in the discovery, development and commercialization of new treatments for life-threatening infectious diseases. Enanta has a deep pipeline of candidates currently in or soon to enter clinical trials for the treatment of respiratory infectious diseases and hepatitis C viral infection.
The Position:
Associate Scientist - Biochemistry/Bioanalysis (Job Code BA02). The candidate will be responsible for enzymatic assays, in vitro/ex vivo drug metabolism studies, and biological sample analysis using LC/MS/MS. This position is ideal for a recent graduate who would like to gain experience in the industry, and training in drug discovery and development process.
Key Responsibilities:
- Manage a bioanalytical lab (including API 3000 and API 4000 Qtrap, etc) and keep the instruments running properly
- Conduct enzymatic assays and in vitro/ex vivo drug metabolism studies, including liver microsome stability testing in different species, cytochrome P450 inhibition, hepatocyte metabolism, and metabolite identification, etc.
- Responsible for non-GLP LC/MS/MS bioanalytical sample analysis
- Participate in multidisciplinary group discussion and decision-making process in anti-infectious drug discovery.
Qualifications:
- B. Sc or M. Sc. in Analytical Chemistry or equivalent with 2+ years of lab experience
- Good written and communication skills
- Motivated and self-driven individual
- Ability to function in a fast paced environment
- Team player
Salary will be commensurate with experience and Enanta offers a generous package of benefits. Learn more about our company by looking at our webpage: www.enanta.com. Qualified candidates should send their resumes, including name, address and phone number of three references, to:
Dr. Lijuan Jiang, Associate Director
Screening, DMPK and Bioanalysis
Enanta Pharmaceuticals, Inc
500 Arsenal Street
Watertown, MA 02472
Email: ljiang@enanta.com
Job description::
Biogen Idec is seeking an experienced pharmacokineticist who will support preclinical and clinical product development teams. The position will located in San Diego and will report to the Director of Development DMPK. Responsibilities will encompass all preclinical and clinical activities related to the development of small molecules and protein therapeutic agents. The individual will work with project team leadership and senior management to set key objectives, plan and execute appropriate studies, interpret data, and report results both verbally and in written form.
The ideal candidate will:
- Be familiar with regulatory requirements and be comfortable working with internal regulatory authorities; this will include generation of submissions and requests for response
- Have strong verbal and written communication and reporting skills
- Be able to anticipate, identify, and/or resolve issues without daily supervision
- Work with functional area leadership to maintain our culture of continuous improvement and scientific excellence
TO APPLY, PLEASE FOLLOW THE URL: http://posttrak.arbita.net/cgi-bin/PostTrak.cgi?RefCode=R9070272106438
Reference Job ID: 8447BR
About Biogen Idec: Transforming Discovery into Care
With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.
Learn more at www.biogenidec.com/careers.
Biogen Idec is proud to be an equal opportunity employer
We are Archemix Corp., a vibrant growing biotech organization where every day matters. Fueled by innovation and guided by compassion, we create aptamer therapeutics that improve the quality of human life.
Based in Kendall Square in Cambridge, MA, we are focused on discovering, developing, and commercializing aptamer therapeutics. Currently, Archemix and its licensees are evaluating five different aptamer product candidates in human clinical trials. We have numerous licensing partnerships with well established and scientifically respected biotechnology and pharmaceutical companies. At Archemix, we are developing aptamers as an exciting new class of oligonucleotide-based therapeutics.
Overview: The Drug Metabolism and Pharmacokinetics (DMPK) department at Archemix is seeking a highly motivated individual with proven abilities who will be involved in the design, execution, supervision, interpretation and communication of PK/ADME and bioanalytical studies. These studies will enable the optimization and selection of aptamer for drug development candidates, and provide assessment of their PK/ADME characteristics to support drug development.
Reports To: Director, DMPK
Direct Reports: 2, possibly 3 direct reports
Responsibilities:
- Provide expert level guidance and work independently as the study director in the design, implementation, data analysis and interpretation of PK/ADME, PK/PD and bioanalytical studies
- Perform and implement both in vitro and in vivo experiments to acquire aptamer PK, PK/PD and ADME properties.
- Perform PK and PK/PD data analysis, modeling, simulation and prediction to provide human dose projection and exposure based on extrapolation from in vivo or in vitro data.
- Represent DMPK in interdisciplinary project teams and provide guidance to implement strategies to enable programs to select drug candidates for nomination into development.
Requirements:
- This position will require knowledge of Pharmacokinetic/Pharmacodynamic modeling to facilitate prediction of the exposure required in humans.
- The candidate must be able to work both independently and successfully collaborate internally in a matrix team environment, and externally with partner companies
- He /she must be able to write reports for IND and NDA filings including the writing of SOP’s.
- The position requires the mentoring /leading of lesser experienced scientists and staff
- He/she must be able to monitor internal and external PK/ADME and Bioanalytical non-GLP and GLP studies.
- The successful candidate will have a PhD degree in Pharmacokinetics, Drug Metabolism, or related field with a minimum of 4+years of industrial experience in the evaluation of oligonucleotide-based or small molecule therapeutics
- The ability to demonstrate excellent knowledge in PK and drug metabolism principles is a must, as is a working knowledge of PK/ADME science as it relates to drug discovery, development, delivery or general disposition.
- Experience in PK, and PK/PD data analysis including PK modeling, simulation and prediction is required
- Familiarity with various PK software packages, such as WinNonLin, ADAPT, SAAMI and NONMEM is necessary.
- The candidate must have working experience and proficiency with HPLC and LCMS instrumentation.
- The candidate must be familiar with laboratory techniques such as in vitro/in vivo metabolism and PK experiments, analysis of drugs and metabolites in biological fluids.
Preferences:
- Prior experience with writing IND’s, BLA’s and/or NDA’s is highly desired
- The candidate should be organized, highly motivated, and have excellent written and oral communication skills. He/she should be detail oriented with the ability to multitask.
PLEASE APPLY ON LINE BY FORWARDING YOUR CV WITH COVER LETTER, REFERENCING JOB CODE DMRHPI040108
Archemix is an equal opportunity employer, welcoming diversity in our workforce.
Agilux Laboratories is an LC/MS/MS, bioanalytically-focused CRO founded by industry veterans who believe that there’s a better way to serve clients than current industry standards. Our founders have over 50 years combined experience at industry leading CROs, from startups through large, mature organizations. Throughout that time we’ve strived to bring the best technology together with the fastest turnaround times and the highest level of service to meet each client’s individual needs. All that we’ve learned comes together at Agilux: high throughput, multiplexed UPLCs paired with Sciex API MS/MS systems, a state-of-the-art purpose built facility in Worcester, MA, and operating systems and processes designed to deliver results in half the time of the competition.
The company has the following positions open.
As a Principal Scientist, individuals in these positions serve as Senior Scientific team members and will be responsible for the overall scientific and operational management of small molecule bioanalytic programs supporting a variety of early to late stage PK/PD studies. While retaining an element of hands-on responsibilities, these positions are largely focused upon leveraging the individual’s scientific strengths through the mentoring and management of more junior staff across multiple programs, scientific areas and client interactions.
Duties and responsibilities include but are not limited to:
- Prepare and extract a variety of biological samples types for quantitative analysis by LC/MS/MS (manual and automated);
- Evaluate and optimize LC and MS/MS conditions necessary to support sample analyses;
- Analyze samples and process post-acquisition data;
- Assemble, review and QC study data sets;
- Troubleshoot assays and data sets as necessary, working with others as necessary;
- Proactively manage and effectively communicate project related issues and expectations with Sponsors as required;
- Effectively mentor and manage the priorities and efforts of junior staff;
- Develop, maintain and enhance commercial relationships with Sponsors;
- Company representation at regional and national scientific meetings as appropriate.
Education
Minimally a 4 year degree, preferred in chemistry, biology or a closely related discipline. A Ph.D. degree beneficial but not required.
Experience
4-8 years of directly related experience with a 4 year degree or 2 to 6 years directly related experience with a Ph.D. Previous industry experience a decided plus.
Skills
- Enthusiasm and a genuine willingness to learn in a team environment where timely, quality data is paramount;
- A dedication to and advocacy of effectively mentoring the professional development and advancement of more junior staff;
- Discipline, self-motivation and exceptional intra- and interpersonal skills;
- Excellent communication skills, both oral and written, including communication with clients;
- Recognizable scientific expertise in all aspects of small molecule bioanalysis and confidence in troubleshooting.
- Confidence in the independent assessment of and solution of a wide variety of scientific problems associated with small molecule bioanalysis by LC/MS/MS
- Ability to effectively manage multiple projects with changing priorities;
- Fully developed abilities to assess and implement new technologies in a commercial environment;
- Previous direct industry experience required; previous GLP experience required, pharmacokinetics experience a strong plus.
As Scientists, individuals in these positions will be increasingly responsible for the overall scientific and operational management of small molecule bioanalytics supporting a variety of early to late stage PK/PD studies. These positions are hands-on and require working closely with more junior staff in a fast-paced environment where a commitment to teamwork, quality data and speed is essential.
Duties and responsibilities include but are not limited to:
- Prepare and extract a variety of biological samples types for quantitative analysis by LC/MS/MS (manual and automated);
- Evaluate and optimize LC and MS/MS conditions necessary to support sample analyses;
- Analyze samples and process post-acquisition data;
- Assemble, review and QC study data sets;
- Troubleshoot assays and data sets as necessary, working with others as necessary;
Education
Minimally a 4 year degree, preferred in chemistry, biology or a closely related discipline.
Experience
1-2 years of experience with a 4 year degree or 0 years experience with a Ph.D. Previous industry experience a decided plus.
Skills
- Enthusiasm and a genuine willingness to learn in a team environment where timely, quality data is paramount;
- Strong intra- and interpersonal skills;
- A high degree of computer literacy in standard software applications, e.g. Excel, Word;
- Excellent attention to detail and general quantitative skills;
- Strong communication skills, both oral and written, including communication with clients;
- Developing scientific expertise in all aspects of small molecule bioanalysis and troubleshooting;
- Emerging skills in the assessment and application of new technologies;
- Ability to effectively manage multiple projects with changing priorities;
- Mentoring and effective direction and management of junior staff;
- Previous direct industry experience required; previous GLP and/or pharmacokinetics experience highly desired.
As an Associate Scientist, individuals will be involved in all aspects of studies supporting the bioanalysis of small drug molecules in multiple matrices. These are hands-on positions working in close cooperation with and under the guidance of more senior staff members in a fast-paced environment where a commitment to teamwork, quality data and speed is essential.
Duties and responsibilities include but are not limited to:
- Prepare and extract a variety of biological samples types for quantitative analysis by LC/MS/MS (manual and automated);
- Evaluate and optimize LC and MS/MS conditions necessary to support sample analyses;
- Analyze samples and process post-acquisition data;
- Assemble, review and QC study data sets;
- Complete documentation as required;
- Working closely with more senior staff, troubleshoot assays and data sets as necessary.
Education
2 year degree minimum, 4 year degree preferred in chemistry, biology or a closely related discipline.
Experience
0-1 year of experience. This position is an entry level scientific position within Agilux Laboratories.
Skills
- Enthusiasm and a genuine willingness to learn in a team environment where timely, quality data is paramount;
- Strong intra- and interpersonal skills;
- A high degree of computer literacy in standard software applications, e.g. Excel, Word;
- Excellent attention to detail and general quantitative skills;
- Strong communication skills, both oral and written;
- Ability to work effectively under minimum direction;
No phone calls – email only
Christine Alberta
Agilux Laboratories
Biotechnology Three
One Innovation Drive
Worcester, MA 01605
t. 508-753-5000
Job description::
The incumbent will be responsible for, but not limited to the following:
- Implementation of M&S strategies, including design and analysis of (population) PK and PK/PD studies, with the support of group members and through outsourcing.
- Conducting PK and PK/PD data analysis, using methods across the spectrum from noncompartmental to population approaches.
- Assist in compilation of PK and PK/PD analysis plans, datasets and reports in accordance with departmental SOPs.
- Interact with clinical, statistics and data management functions.
- Represent the company at major scientific and medical meetings.
- To maintain knowledge of PK, PK/PD and modeling and simulation approaches.
Qualifications::
- An astute pharmacokineticist with demonstrable, hands-on experience in population PK/PD, Modeling and Simulation, using NONMEM and S-Plus / R, SAS, Matlab, WinBugs.
- A higher degree with relevance to PK/PD, modelling and simulation
- Experienced with strategic application of modelling and simulation to drug development, gained within the pharmaceutical industry (i.e. Pharma or CRO)
- Understanding of the requirements of GCP.
- Experience with working in multi-disciplinary teams
- Proactive with excellent communication, organizational and mentoring skills.
Location and salary::
Northern NJ -competitive salary and bonus structure
General Summary::
Eisai's corporate philosophy focuses on meeting the diverse needs of
patients and their families and increasing the benefits that health care
provides. We express this philosophy with the phrase "human health
care," and continue to concentrate efforts on its realization worldwide.
Throughout the company's 64 years of operation, drug discovery has been
an integral part of its mission to advance human health care for
patients and their families, as well as a major contributor to Eisai's
success. Today, Eisai is Japan's fourth largest pharmaceutical company,
ranking in the top 25 worldwide. Eisai's global R & D efforts are
focused in several therapeutic areas, including central nervous system,
oncology, gastrointestinal, and inflammatory diseases. Eisai Research
Institute (ERI) in Andover, MA, is the center for Eisai's U.S. research
and development, with an emphasis on finding new treatments for immune
disorders and cancer.
Primary responsibilities, specific duties::
- Conducts in-vitro metabolism studies, including cell culture,
inhibition/induction, metabolic enzymes/pathway identification.
- Responsible for ensuring compliance with regulatory guidelines.
- Plans, designs and initiates studies, and analyzes the data in
preparation for final reports.
- Attend project meetings and provide constructive feedback.
- Coaching and mentoring junior staff.
Qualifications/Skills::
- Ph.D. in Biochemistry/Pharmacology
- 5-10 years of industry experience
- Solid background in biochemistry and enzyme kinetics
- Self motivator who works well in a team environment
- Flexibility to accommodate changing priorities and deadlines
- Highly analytical with excellent technical and problem solving skills
- Excellent oral and written communication skills
Eisai offers an outstanding compensation and benefits package, including
401(k) match.
Please fax or forward your CV (resume) to:
Human Resources
Eisai Research Institute
4 Corporate Drive
Andover, MA 01810-2441
fax: (978) 681-8731
Email: hr_eri@eisai.com
For more information and other job postings, please visit the Eisai
Research Institute web site at: www.eisairesearchinstitute.com
Eisai Research Institute conducts background checks and pre-employment
physicals. We are an equal opportunity employer M/F/D/V
Enanta Pharmaceuticals, located in Watertown, MA, is a biopharmaceutical company engaged in the discovery, development and commercialization of new treatments for life-threatening infectious diseases. Enanta has a deep pipeline of candidates currently in or soon to enter clinical trials for the treatment of respiratory infectious diseases and hepatitis C viral infection.
The Position::
We have an immediate Associate Scientist or Scientist (depending on education and experience) opening. The candidate will be responsible for non-GLP bioanalytical method development, biological sample analysis and in vitro/in vivo drug metabolism studies. He/She must be able to work independently with minimal supervision.
Key Responsibilities::
- Manage a bioanalytical lab (including API 3000 and API 4000 Qtrap, etc) and keep the instruments running properly.
- Develop LC/MS/MS methods for antibiotics and anti-Hepatitis C compounds
- Responsible for non-GLP LC/MS/MS bioanalytical sample analysis (including plasma and tissues, etc)
- Conduct in vitro/in vivo drug metabolism studies (including cytochrome P450 inhibition, microsomal stability and metabolite identification, etc).
- Participate in multidisciplinary group discussion and decision-making process in anti-infectious drug discovery.
Qualifications::
-
- Associate Scientist: MS / BS in Bioanalysis and Drug Metabolism or equivalent with 2+ years of hands-on experience on LC/MS/MS.
- Scientist:PhD in Bioanalysis and Drug Meatbolism or equivalent with 2+ years of hands-on experience on LC/MS/MS.
- Knowledge of in vitro/in vivo drug metabolism studies. Hands-on experience with metabolite identification using API 4000 Qtrap is a plus
- Good written and communication skills.
- Ability to function in a fast paced environment is necessary.
Salary will be commensurate with experience and Enanta offers a generous package of benefits. Learn more about our company by looking at our webpage: www.enanta.com. Please send your resume to: hr@enanta.com with the code: BA01.
Founded in 2003, Acceleron Pharma, Inc. is a biopharmaceutical company developing therapeutics for musculoskeletal, metabolic and cancer-related diseases. In the complex and rapidly evolving field of drug discovery and development, the depth of the team and the way the team members work together are two of the most critical success factors. We have a unique culture, team, and approach that is rapidly translating our ideas and assets into drugs that will make a significant difference in patients' lives.
Acceleron has raised over $85M in venture financing including $31M from our Series C financing in October 2007. We have assembled a strong management and scientific team comprised of established leaders with significant biotechnology and pharmaceutical industry experience. We are seeking talented and passionate individuals who thrive in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success.
Position Overview:
This position will be responsible for the development and oversight of Acceleron's Discovery and Preclinical Development DMPK function in a manner that conforms to established industry standards and relevant regulatory guidelines. The position will report to the Director of Preclinical Safety.
Job Responsibilities:
Design, interpret, and report pharmacokinetic studies and toxicokinetic components of toxicology studies in animals in support of preclinical and clinical development
- Guide clinical team members in selection of dose, dose formulation, route of administration and dose frequency in Phase I clinical study design
- Actively participate in interdisciplinary project teams dedicated to planning and execution of INDs and other regulatory submissions
- Peer review reports and regulatory submissions for GLP compliance, completeness and scientific merit
- Interact with Quality Assurance to schedule and resolve audits
- Create and modify standard operating procedures as needed
- Create and modify laboratory methods as needed
- Develop organizational growth and outsourcing strategies for DMPK function
Required Experience
Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related discipline with at least 5 years of industry and/or related DMPK experience. Prior experience in the development of biotherapeutics is preferred. The candidate should have the following:
- Extensive knowledge of pharmacokinetic and pharmacodynamic principles
- An overall understanding of drug research and development
- A thorough knowledge of preclinical and clinical pharmacology
- Project team experience representing the preclinical DMPK function
- Working familiarity with Good Laboratory Practice (GLP) Regulations
- Experience in preparation of regulatory submissions and interaction with regulatory authorities on preclinical and clinical DMPK issues
- An overall understanding of small molecule and biotherapeutic method validation, bioanalytical sample analysis, and various instrumentations (HPLC, LC/MS/MS, GC, ELISA, Biacore, etc.)
- Experience with analytical software such as WinNonlin, NONMEM, or similar programs
- Experience monitoring bioanalytical studies at CROs
- Basic understanding of principles of toxicology, molecular biology, and immunology.
For immediate consideration, please visit www.acceleronpharma.com
Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Founded in 1992, Cubist is headquartered in Lexington, MA. For more information about the company, please visit our website at www.cubist.com.
Position Summary:
As Nonclinical Pharmacokinetic Scientist in the Nonclinical Development Department he or she will design and oversee the nonclinical pharmacokinetics / ADME testing for discovery analog and IND candidates in development. Specific responsibilities will include: nonclinical PK study design, contract research laboratory (CRO) selection / PK study director interactions, PK analyses and study result interpretation, in-house toxicokinetics analyses and report finalization, and preparation of integrated nonclinical PK summaries for IND and NDA submissions.
Duties and Responsibilities:
- Design nonclinical pharmacokinetics testing program and the studies to be conducted as part of this program (including in vitro metabolic stability, P450 inhibition and induction, in vivo pharmacokinetics / ADME studies in animal models, drug interaction studies) for discovery analog and IND candidates
- Design and oversee in-house in vitro metabolic stability / profiling across animal species,
metabolic inhibition / interaction studies
- Design / PK data analysis (with modeling) for in-house animal PK studies (Tier 2 - 4)
- Design in vitro / in vivo metabolism, metabolite ID, drug interaction studies (inhibition / induction / CYP mapping) for IND candidates
- Design, oversee, interpret results of GLP animal PK / ADME studies conducted at CROs
- Assists Analytical Research on bioanalytical method development and validation and reviews primary plasma concentration data
- Review and finalize PK study reports
- Perform all (non-GLP and GLP) toxicokinetics analyses for Tier 3 / 4 and IND repeat dose toxicity studies and finalizes reports
- Serve on selected project teams and/or subteams
- Reviews PK characterisitics of IND candidates and in collaboration with Discovery, Nonclinical, and Clinical scientists determines dosing regimen to optimize for efficacy and minimize toxicity
- Collaborate with Discovery Research in the PK screening of analog candidates
- Evaluates PK issues for in-licensing assessments
- Recommend and implement selected nonclinical PK testing to evaluate in-licensing candidates
- Prepare all relevant PK sections of nonclinical regulatory documents (study summaries, CTD tables, Annual Reports, Investigator Brochures, and integrated summaries for regulatory submissions) and respond to issues
- Some travel - ~10% of time
Qualifications
1. Education/Certification
Successful candidates will have a Ph.D in pharmacokinetics or pharmaceutical sciences. Post-doc experience preferred.
2. Experience
2-4 years of relevant experience with Ph. D degree as a nonclinical pharmacokineticist within the biopharmaceutical industry; CRO testing experience preferred
3. Knowledge, Skills, and Abilities
Candidates must be familiar with the worldwide nonclinical pharmacokinetics testing guidelines to support clinical development and registrational filings. Experience with WINNONLIN, pharmacokinetics modeling, and in silico predictive PK is desirable.
To apply, e-mail resume and cover letter to: jobs@cubist.com
Sai Advantium Pharma Ltd. (www.saiadvantium.com) is a fast growing, contract service organization in India that has established credentials in providing dedicated services for Medicinal Chemistry and Chemical Development. The company is currently focusing on expanding their services in DMPK for lead selection and optimization stages at their Pune site. Sai advantium is now looking for highly motivated, dedicated, and four competent individuals to build bioanalytical, biotransformation, in vivo PK and laboratory animal resources (LAR) groups, respectively, within the DMPK department. We seek focused, self-motivated, creative, independent-thinking and dedicated individuals to head these groups within DMPK department. We offer a competitive salary plus attractive stock options and a full range of benefits. We seek individuals with leadership potential so that they can grow with the company. For consideration, send your resume and a concise e-mail describing your qualifications to manisha.c@saiadvantium.com
Associate Director/Director, Head, Bioanalytical group:
An Associate Director/Director position is available immediately to build and lead the Bioanalytical Group at Sai advantium. This position directly reports to the Vice president, DMPK and carries the following responsibilities:
1) Build a strong bioanalytical group of 10 – 12 scientists and be the key bioanalytical representative for the external clients. Provide strong leadership in building and managing world-class bioanalytical group. An initial phase of the job responsibility is to provide bioanalytical support for the PK studies during lead selection and optimization stages. In the long-run, a strong GLP-based support of regulatory pharmacokinetic and toxicokinetic studies is expected. Be part of the company’s core leadership team and participate in the bioanalytical strategies.
2) Be a strong leader of bioanalytical group and provide high quality scientific and technical guidance on bioanalytical assay development and validation. Supervise bioanalytical assay development, validation and analysis activities, as well as preparing protocols, reports, SOP’s plus personnel and budgetary issues. Interact with clients and promptly deliver the documents (data, reports) to the clients and immediate management in a timely manner.
Qualifications: Candidates should have a Ph.D. or equivalent degree in chemistry, biochemistry, or life sciences. The successful candidate will have at least 8 years experience in development and validation of bioanalytical assays using the state-of-the art LC-MS instrumentation. Experience in qualitative metabolite identification is a strong plus. In addition, the bioanalytical department will also be involved in developing LC-MS methods for protein-binding, in vitro drug-drug interaction and drug-transport studies. The candidate must have sound knowledge and understanding in GLP/GMP regulations and LIMS systems. Prior supervisory/management experience is required, and project management skills will be a plus. Strong communication and people skills are expected. Candidate should enjoy and work well in a fast-paced, multi-tasked, and hands-on environment.
Associate Director/Director, Head, Biotransformation:
Sai Advantium Pharma Ltd. (www.saiadvantium.com) is a fast growing, contract service organization in India that has established credentials in providing dedicated services for Medicinal Chemistry and Chemical Development. The company is currently focusing on expanding their services in DMPK for lead selection and optimization stages. Sai advantium is now looking for highly motivated, dedicated, and competent individual to build a strong In Vitro and In vivo metabolism group within DMPK department.
An Associate Director/Director position is available immediately to head the build and lead the biotransformation group within DMPK department, at Sai advantium. This position directly reports to the Vice president, DMPK and carries the following responsibilities:
The incumbent will be responsible for building a group of 10 – 12 scientists to carry out in vitro biotransformation studies. Be the key drug metabolism representative for external clients. Provide strong leadership in building and managing world-class biotransformation group. Establish and lead the in vitro biotransformation function area including conducting in-vitro studies addressing issues related to metabolism in both discovery and early development programs. This person will closely interact with medicinal chemists and ensures that molecules are optimized with respect to biotransformation properties during lead selection and lead optimization stages. This person is primarily responsible for establishing in vitro tools for drug metabolism, drug interaction and drug transport studies. Closely works with in vivo PK group for in vivo support for in vivo metabolism studies. Closely works with bioanalytical group for analytical support for drug metabolism related studies including in vitro drug-drug interaction, CYP identification, CYP inhibition, metabolite identification, protein-binding, and for determining the metabolic fate of molecules during discovery and early preclinical development. This person is also responsible for keeping abreast of new scientific developments and technologies for drug metabolism studies, as needed, and makes recommendations to the immediate management.
The incumbent must be a strong leader of biotransformation group and provide high quality scientific and technical guidance on assay development and validation. Supervise drug metabolism assay development, validation and analysis activities, as well as preparing protocols, reports, SOP’s plus personnel and budgetary issues. The candidate is expected to interpret the biotransformation data including proposing the drug metabolism pathways, understanding the clinical significance of in vitro data and make recommendations for project advancement. The incumbent is expected to be the primary contact for external clients regarding biotransformation data and promptly deliver the documents (data, reports) to the clients and immediate management in a timely fashion.
Qualifications: Candidates should have a Ph.D. or equivalent degree in chemistry, biochemistry, or life sciences. The successful candidate will have at least 8 years’ experience in development and validation of drug metabolism assays using in vitro tools including protein-binding, in vitro drug-drug interaction and drug-transport studies. Prior supervisory/management experience is required, and project management skills will be a plus. Strong communication and people skills are expected. Candidate should enjoy and work well in a fast-paced, multi-tasked, and hands-on environment.
Associate Director/Director, Head, In vivo DMPK group:
Sai Advantium Pharma Ltd. (www.saiadvantium.com) is a fast growing, contract service organization in India that has established credentials in providing dedicated services for Medicinal Chemistry and Chemical Development. The company is currently focusing on expanding their services in DMPK for lead selection and optimization stages. Sai advantium is now looking for highly motivated, dedicated, and competent individual to build a strong In Vitro and In vivo metabolism group within DMPK department.
An Associate Director/Director position for establishing and leading the in vivo DMPK group is available immediately in the at Sai advantium. This position directly reports to the Vice president, DMPK and carries the following responsibilities:
The incumbent will be responsible for building a group of 10 – 12 scientists to carry out in in vivo DMPK studies. Be the key pharmacokinetics representative for external clients. Provide strong leadership in building and managing world-class in vivo DMPK group. Establish and lead the in vivo metabolism and pharmacokinetic function area including conducting the non-radiolabeled and radiolabeled in vivo studies, for both discovery and early development programs. This person will closely interact with medicinal chemists and ensures that molecules are optimized with respect to pharmacokinetic properties during lead selection and lead optimization stages before molecules are transitioned into early development. Closely works with bioanalytical, biotransformation and laboratory animal resource groups. Should be proficient in understanding animal care and handling techniques and will be the key in vivo PK group representative on IACUC committee.
The incumbent must be a strong leader of pharmacokinetics and provide high quality scientific and technical guidance on in vivo PK and metabolism study designs. Supervise in vivo pharmacokinetic and drug metabolism studies nd validation activities as well as preparing study protocols, reports, SOP’s, IACUC protocols plus personnel and budgetary issues. The candidate is expected to interpret the pharmacokinetic data with a sound knowledge in utilizing Win-Nonlin for PK analysis, allometric scaling and understanding the clinical significance of in vivo data and make recommendations for project advancement. The incumbent is expected to be the primary contact for external clients regarding pharmacokinetic data and promptly deliver the documents (data, reports) to the clients and immediate management in a timely fashion.
Qualifications: Candidates should have a Ph.D. or equivalent degree in pharmacy, chemistry, biochemistry, or life sciences. The successful candidate will have at least 8 years’ experience in development and validation of pharmacokinetic in vivo assays and analysis using Win-nonlin software. Prior supervisory/management experience is required, and project management skills will be a plus. Strong communication and people skills are expected. Candidate should enjoy and work well in a fast-paced, multi-tasked, and hands-on environment.
Associate Director/Director, Head, Laboratory Animal Resources (LAR):
Sai Advantium Pharma Ltd. is seeking a veterinarian for the position of Associate Director, Office of Laboratory Animal Resources (LAR). The Associate Director, will be the Attending Veterinarian, will have clinical and managerial responsibilities for the animal facilities that house a wide-range of research animal species for drug metabolism and toxicology studies. The incumbent is expected to provide medical and surgical care for the animals housed in these facilities and to advise on colony management and animal health. The position will also require running quality assurance, and diagnostic pathology programs. The Associate Director will directly report to the Vice President, DMPK and also have the opportunity to recruit 3 – 5 associate veterinarians.
The Associate Director will manage veterinary and animal care technician staff of LAR.. The Associate Director is expected to serve on the Institutional Animal Care and Use Committee (IACUC) and to provide clinical oversight to this committee. The Associate Director will also help the facility to obtain AAALAC accreditation, assure compliance with CPSCEA regulations and guidelines, and work with administrators and facilities personnel to design new animal holding space and identify equipment to best fit the needs of the growing research program and the animals’ welfare. The incumbent is also expected to serve on institutional committees (e.g.- Biohazard, and/or Chemical Hygiene) where appropriate. The incumbent will collaborate with in vivo scientists in DMPK and Toxicology, to provide novel approaches and solutions to commonly encountered research questions or obstacles. Work with project teams to implement the possible solutions. You will also participate in audits of our facilities by external clients to ensure compliance with.
Qualifications: A D.V.M. (or V.M.D.) or combined D.V.M./Ph.D. with outstanding clinical, managerial, and leadership skills. Candidates must have at least 8 years “laboratory animal medicine” experience. Strong knowledge on international and national laws and regulations regarding animal care and use is required. Prior supervisory/management experience is required, and project management skills will be a plus. Strong communication and people skills are expected. Candidate should enjoy and work well in a fast-paced, multi-tasked, and hands-on environment.
For consideration, send your resume and a concise e-mail describing your qualifications to manisha.c@saiadvantium.com
The Bioanalytical Development group within the Analytical Biochemistry and Formulations department is seeking a Senior Scientist to develop and implement assays to investigate in vivo pharmacokinetic and immunogenicity responses in support of non-clinical and clinical studies.
Major Duties and Responsibilities:
- Overseeing the development, validation and implementation of PK and immunogenicity assays in a GLP-compliant laboratory
- Outlining assay strategies to meet product development and regulatory needs from the pre-clinical stage through the clinical phases and to product registration
- Serving as principal investigator for in-house, GLP sample testing studies
- Overseeing validation and sample analysis at external contract laboratories
- Contributing to in-house GLP operations and sample management
- Supervising research associates
- Collaborating with cross-departmental clinical, pharm/tox, research and QC/QA teams
- Technical report writing and editing as well as knowledge of GLP regulations and current industry guidance for bioanalytical assays, will be integral to this position
Depending on the candidate’s experience, responsibilities may also include:
- Developing new assays using electrochemiluminesence formats
- Developing neutralizing assays, immune response characterization studies, product release assays
Requirements:
- PhD in the biological sciences, chemistry or a related discipline
- Minimum of five years laboratory experience in the biotechnology or pharmaceutical industry with a GLP or GMP component
- Hands-on proficiency with ELISA, ECL, and/or analytical or bioanalytical assay development is strongly preferred
- Familiarity with potency assays or cell-based assays is a plus
- Experience managing research associates and managing multiple projects in a fast-paced environment
- Experience working with the Watson LIMS in a GLP regulatory environment is desirable
- Excellent analytical skills, oral and written communication skills, as well as a demonstrated ability to operate both independently and in team settings
To apply, please email Robert Loomis at rloomis@seagen.com
We are currently looking for an experienced biotransformation leader to join a growing, dynamic team within our Drug Metabolism and Pharmacokinetics department. The incumbent will be responsible for establishing and leading the Biotransformation functional area and conducting in-vitro and in vivo studies addressing issues related to metabolism in both discovery and development programs. Further, this person will be expected to develop a strategy for ensuring that molecules are optimized with respect to biotransformation properties before molecules are transitioned into development, and for determining the metabolic fate of molecules during preclinical and clinical development. The incumbent is also responsible for generating and monitoring technologies within the DMPK department to keep abreast of new scientific developments. The incumbent will represent DMPK on cross-functional discovery and development project teams. The position reports to the Vice President of Drug Metabolism and Pharmacokinetics.
The duties include but are not limited to the following:
- Build a team of scientists who will be providing biotransformation expertise for all discovery and development programs
- Provide scientific direction in biotransformation and be a spokesperson for this discipline as well as more broadly for DMPK
- Integrate biotransformation strategy with Discovery DMPK and Development PK
- Provide managerial guidance and act as a mentor to develop staff
- Equip laboratories and build new technologies to continually advance the science in biotransformation
- Provide timely presentations, reports and documents for world-wide regulatory registrations; respond to regulatory inquiries
- Lead interdisciplinary teams
Qualifications:
- In depth conceptual and technical expertise in biotransformation and drug discovery and development, and ability to provide strategic and scientific direction in this area
- Industry thought leader with demonstrated record of scientific publications and presentations
- Solid experience leading a group of Ph.D. scientists in biotransformation
- Excellent organizational, interpersonal and communication skills
- Demonstrated experience in team environment and ability to lead teams
- Experience with multiple regulatory submissions
About Biogen Idec: With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.
Apply at URL: http://posttrak.arbita.net/cgi-bin/PostTrak.cgi?RefCode=R2511272106330
Primary duties include the determination of in vivo metabolic
pathways in animals and humans. The elucidation of metabolic
pathways involves the identification and quantification of
metabolites in biological matrices (eg. blood excreta) using
HPLC with radioactivity detection and/or LC-MS/MS. Accordingly,
the position requires expertise in sample preparation as well
as subsequent analysis. Additionally, in vitro metabolism
experiments and determination of metabolic pathways in
microsomal incubations and liver slices need to be performed to
compare metabolic pathways across species and assess the
potential drug-drug interactions in humans (identification of
enzymes involved and inhibition studies). The determination of
enzyme kinetic parameters may also be required.
Minimum requirements:
M.S. in Chemistry or Biochemistry or related field with a
minimum of three years or B.S.with five years of hands-on
experience with HPLC and LC-MS/MS. Prior experience with
radioisotope handling (eg. 3H, 14C), biochemical techniques and
in vivo and in vitro metabolism is required. The candidate
should be capable of working independently under moderate
supervision and should possess good writing and verbal
communication skills. An excellent working knowledge of general
laboratory techniques, HPLC and LC-MS/MS operation,
troubleshooting and method development is essential. A strong
background in analytical problem solving is also required.
Required years of experience:
Three - Five Years
Please apply via www.novartis.com with the job ID 33211BR.
Position Summary:
Evaluate and develop candidate drug products using biopharmaceutical,
pharmacokinetic/ pharmacodynamic, and drug therapeutic principles and
knowledge of drug regulatory processes.
Position Responsibilities:
Identify preclinical data (e.g., ADME, pharmacology, toxicology, etc.)
needed for product evaluation and design of clinical studies and
development plans. Develop detailed preclinical development plans and lead
execution of preclinical programs acceptable to regulatory authorities;
apply principles of drug development science and regulatory science to
build thorough but efficient preclinical development plans. Participate
with various internal and external disciplines in the research and
development of selected drug products.
Qualifications:
PhD in a health sciences discipline with 10 years research experience.
Experience with research in multiple therapeutic areas a plus. Excellent
scientific writing, communication, presentation, documentation, and
computer skills. Experience with application of drug development science
(e.g., ADME, PK and PK/PD methods and simulation, statistics, etc.) to
streamline drug development required; experience interacting with
regulatory authorities desired. Desire to work in cross-functional drug
development team environment with all levels of employees and management;
ability to lead such teams valued. Ability to work internationally and
across multiple corporate sites.
For more information please contact www.pkrecruiting.com
The Director, Bioanalytical Development will manage day-to-day activities
and priorities of the Bioanalytical Development group. In doing so, this
position will develop bioanalytical LC-MS/MS methods for the quantitative
analysis of small molecule drugs and the metabolites in plasma and other
biological matrices in support for the toxicology and clinical PK studies.
In addition, this individual will oversee the transfer of bioanalytical
methods for Contract Research Organizations (CROs). The successful
candidate will also provide mentoring and guidance to the staff; interpret
and provide bioanalytical results to other DMPK scientists and project
teams, and be responsible for reporting data in various formats, including
GLP-compliant validation and bioanalytical reports. While performing the
above, the incumbent will also manage multiple projects while meeting
internal and external timelines through productive interaction with QC, QA
and PM functions.
Qualified candidates will possess:
MS in Bioanalytical Chemistry and 3-5 years of related industry and
supervisory experience in a GLP environment with strong emphasis on
LC/MS/MS bioanalysis, including laboratory automation and sample
preparation techniques; PhD and 7-10 years experience preferred
Hands-on experience with LC-MS/MS; including extensive experience in
the development of the LC-MS/MS bioanalytical methods for support of
GLP-compliant pre-clinical and clinical studies
Thorough understanding of GLP regulations and extensive experience
working with QA; Excellent verbal and written communication skills
For more Information please contact info@greylock-recruiting.com
Responsibilities
- Develop quantitative analytical methods for biological matrices in
support of pharmacokinetic studies in various stages of drug
discovery and development
- Provide general analytical support for pharmacokinetic and metabolism
studies
- Establish LCMS assays for in vitro metabolism and train new users
- Work in a team environment where timely delivery is essential
- Plan, manage and supervise outsourcing activities during
bioanalytical method transfer, method validation and sample analysis
in GLP studies to ensure quality and adherence to timelines
- Ensure that regulated studies are in compliance with GLP/FDA/ICH
guidelines
- Develop suitable procedures to facilitate bioanalytical work
in-house
- Write and review analytical protocols and reports
- Readily adjust plans to changes made in project priorities
Education / Experience
- PhD or Masters degree in analytical chemistry and more than 5 years
of experience from pharmaceutical industry
- Strong skills in separation science and quantitation of small
molecules using LC-MS/MS
- Extensive experience in biological sample analysis and different
sample extraction techniques
- Profound knowledge in GLP and regulatory guidelines for bioanalysis,
strong problem solver and good report writing and communication
skills
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is
a biopharmaceutical company engaged in the discovery, development and
commercialization of drugs for the treatment of human viral and other
infectious diseases. Idenix's current focus is on the treatment of
infections caused by hepatitis B virus, hepatitis C virus and human
immunodeficiency virus. For further information about Idenix, please refer
to www.idenix.com.
Idenix offers an excellent benefits package including competitive salary,
equity compensation, major medical insurance, dental insurance, 401(k) plan
participation, and group life and disability insurance.
To be considered for this position, please send your resume by email to hr@idenix.com or by mail to
Human Resources
Idenix Pharmaceuticals
60 Hampshire Street
Cambridge, MA 02139
The company is looking for a Senior Scientist, DMPK to perform and oversee
all bioanalytical efforts for the quantitative analysis of drugs and
metabolites in biological matrices in support of the company’s drug
discovery and development efforts.
Responsibilities
This position is looking for someone to develop analytical methodologies,
primarily LC-MS/MS based approaches for conducting these assays. Knowledge
of the principles of pharmacokinetics is required for modeling and
interpretation of pharmacokinetic data. Similarly, strong laboratory skills
are required for various sample preparation approaches and the use of mass
spectrometry. Good written / oral communication and organizational skills
are mandatory as communications across functional lines are required. The
ability to interpret PK and TK data to assist in understanding both
efficacy and toxicity findings in context with drug exposure data are also
necessary. Expertise in the development of rapid LC-MS/MS methods, sample
extraction techniques and maintenance of mass spectrometry instrumentation
to enhance delivery time of analytical data are also important.
Requirements
- Ph.D. with 5 or more years of experience
- Must have a very good understanding of Bioanalytics and the ability to
independently design, implement and complete bioanalysis for the
assessment of NCE’s as well as analyze and report pharmacokinetic data
(WinNonlin modeling)
- Experience in managing scientific staff
- Strong skills in using and maintaining mass spectrometry equipment
- Must have good documentation and communication skills, attention to
detail, and strong problem-solving skills
- Ability to work in a multidisciplinary team environment
Please contact
Erin McDevitt
Scientific Recruiter
ClinLab Staffing
www.clinlabstaffing.com
2 International Place, Suite 1710
Boston, MA 02110
Ph: 617.778.0483
Fax: 617.778.0484
Inotek Pharmaceuticals, Beverly, MA is looking for an Associate Director - DMPK.
Requirements
- Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or related discipline with 5-10 years of industry and/or related ADME/PK experience.
- Has an overall understanding of drug research and development.
- Experience directing nonclinical ADME/PK.
- Extensive knowledge of pharmacokinetic and pharmacodynamic principles.
- A thorough knowledge of clinical pharmacology.
- Experience in preparation of regulatory submissions.
- Experience interacting with regulatory authorities on nonclinical ADME/PK and Clinical Pharmacology/Pharmacokinetic issues.
- Knowledgeable in GLP, ICH and regulatory guidance.
- Experience with advanced data analysis skills.
- Has an overall understanding of method validation, bioanalytical sample analysis, and various instrumentations (HPLC, LC/MS/MS, GC, etc.).
- Knowledgeable of the expertise of CROs and experience in monitoring bioanalytical studies at CROs.
- Excellent written and oral communication skills.
Responsibilities and accountability
- Responsible and accountable of the nonclinical ADME/PK components of the drug development.
- Develop nonclinical ADME/PK programs in development stage.
- Support toxicology studies, as needed (toxicokinetics, tissue drug levels, tissue enzyme evaluation, etc.).
- Assist in studies to support formulation screening.
- Help support nonclinical ADME/PK needs for programs in early discovery stage.
- Help develop and design clinical pharmacology studies, analyze data (pharmacokinetics, pharmacodynamics, dose/concentration response), and report results.
- Evaluate CROs, coordinate all study-related functions, monitor the development of analytical methods and samples bioanalysis from non-clinical PK studies.
- Manage study logistics and CROs to execute nonclinical ADME/PK studies.
- Provide operational leadership for all assigned studies/programs and manage CROs and vendors to ensure consistency of method interpretation and approach.
- Summarize interpretation of the study data for presentation to management and project team.
- Compile nonclinical ADME/PK and clinical pharmacology sections of Investigator Brochures, IND/CTA, and other regulatory submissions.
- Interact and respond to regulatory agencies, as needed.
- Assist in resource and/or budget planning.
To apply:
Please send your resume via e-mail to inotekcorp@vurvexpress.com
In the Subject line, please specify the job number as 463276.
Achillion Pharmaceuticals is an innovative biopharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. We are looking for a self motivated, innovative individual to support our drug discovery process. As a member of the Preclinical Candidate Section team you will be supporting in-house analysis, characterization of small molecule drug physico-chemical, ADMET, & PK properties, and pre-clinical testing of our early stage compounds. This position will work closely with Achillion’s chemistry, antiviral and antimicrobial research areas.
Essential duties
- Performing in vitro assays to characterize ADMET properties of drug candidates
- Management, interpretation, and presentation of data to support the Drug Discovery Programs
- Expanding the capabilities of the PCS group through the development and execution of new assays and ADMET techniques
- Other duties as assigned
Minimum qualification requirements - Core competencies
Excellent analytical/problem solving skills with the ability to think critically when evaluating results. Strong attention to detail is necessary. Strong organizational skills and the ability to prioritize & multitask are required. Must be able to work independently under general supervision as well as function effectively within a team environment. Outstanding communication skills, written and oral, are required. The ability to integrate experimental results into the drug discovery and development process is required.
Knowledge of:
Knowledge and experience with ADME and PK in drug discovery and assay development is required. A successful candidate must be able to apply their technical skills to conduct protein binding, assays for chemical and metabolic stability, and drug-drug interaction assays. General lab safety and maintenance procedures required. Familiarity with Microsoft Office products and Prism software is required.
Education:
B.S. / M.S. in Pharmaceutics / Biology / Analytical Chemistry / Biochemistry.
Experience:
2-5 years in Drug Metabolism Pharmacokinetics with significant experience in an industry environment as a member of drug discovery team preferred. Analytical or bioanalytical experience a plus. Experience with formulation development a plus
To apply:
For prompt consideration for this position, please send you resume and the names of three references to:
Human Resources
Achillion Pharmaceuticals
300 George Street
New Haven, CT 06511
jobs@achillion.com
Please reference Job Code: PCS
Please no telephone inquiries
Biogen
Idec (Cambridge, MA) is one of the fastest growing biotechnology companies
in the world and a market leader in oncology, neurology, and immunology.
We are currently expanding our small molecule programs to match our
strong presence in biologics. We lead the search for new treatments
that make it possible for patients in more than 90 countries to move
closer to the life they want. Biogen Idec's contributions have twice
been acknowledged by the Nobel Prize Committee.
Role Description & Responsibilities
We are currently looking for
an experienced DMPK scientist to join a growing, dynamic Bioanalytical
Sciences group within the DMPK department. The incumbent will
design, support, and direct the bioanalytical processes for small molecule
discovery and development. Initially the person will be an individual
contributor with project management responsibilities. The duties
include but are not limited to the following:
- Designing, guiding,
and directing the following studies/analytical processes: method development,
method validation, and bioanalytical sample analysis using LC/MS/MS;
- Troubleshooting
instrumentation/method problems and directing other colleagues in the
group to do so effectively;
- Managing multiple
simultaneous projects: workload, deliverables, and deadlines.
- Setting work flows/standards
for various studies and making sure that they are followed by other
group members;
- Writing, reviewing,
and approving protocols/reports on method validations, plasma sample
analysis, and dosing solution analysis. Providing direction to others
in preparing protocol/reports.
- Preparing portions
of regulatory submissions related to method validation and bioanalytical
sample analysis;
- Serving as bioanalytical
domain expert for small molecule programs and represent the Bioanalytical
Sciences group on various project teams;
- Acting as a liaison
between groups within DMPK: Bioanalytical Sciences group, PK, Discovery
DMPK, and Biotransformation. Also serving as a liaison between
DMPK and other departments: Pharmacology, Chemistry, Biology, and Toxicology
for studies supported;
- Interacting with
CROs during method transfers, methods development, method validation,
and sample testing. Supervising/monitoring bioanalytical studies at
CROs. Reviewing and approving method validation data/reports,
and sample testing data/reports from CROs. Directing others in
transferring methods to CROs.
Requirements
- PhD or equivalent
in a science major such as Chemistry or Biochemistry;
- >8 years experience
in pharmaceutical industry or contract research organization;
- Proficiency with
LC/MS/MS systems (e.g. AB Sciex API 3000/4000), experience with Watson
LIMS, experience with liquid handling systems such as Tomtec, Tecan,
Packard, and EP3;
- Experience in managing/conducting
bioanalytical studies in a GLP environment;
- Excellent organizational,
interpersonal and communication skills;
- Solid experience
in people and performance management.
Biogen Idec
Biogen Idec (HQ in Cambridge, MA) is one of the fastest growing biotechnology companies in the world and a market leader in oncology, neurology, and immunology. We are currently expanding our small molecule programs to match our strong presence in biologics. We lead the search for new treatments that make it possible for patients in more than 90 countries to move closer to the life they want. Biogen Idec's contributions have twice been acknowledged by the Nobel Prize Committee.
Role Description & Responsibilities
We are currently looking for an experienced DMPK scientist to join a growing, dynamic Discovery DMPK team within our Drug Metabolism and Pharmacokinetics department. The incumbent will be responsible for conducting in-vitro and in vivo absorption studies addressing issues related to GI absorption, transporter mediated hepatic and renal uptake and efflux, brain penetration and drug drug interactions. Further, this person will be expected to incorporate this information with in-vivo pharmacokinetic data. The incumbent is also responsible for generating and monitoring technologies within the DMPK department to keep abreast of new scientific developments. The incumbent will represent DMPK on cross-functional discovery project teams.
The position reports to the Head of the Discovery DMPK team. The incumbent is expected to build a drug absorption and transporter team and effectively supervise direct reports.
Requirements
- Ph.D. or equivalent
in Biochemistry, Pharmaceutical Chemistry, Pharmacy, or a related science;
- 5+ years of relevant
industry experience;
- Up-to-date knowledge
of drug transporters and metabolizing enzymes. Knowledge of drug
metabolism, enzyme kinetics, pharmacokinetics, and molecular biology;
- Experience in conducting
in-vitro absorption and transporter studies using cell-based and cell
free models to address intestinal absorption, hepatic and renal uptake
and efflux, blood brain barrier issues as well as determine potential
for drug interactions.
- Experience in cell
culture, cellular and molecular biology related techniques (e.g. western
and northern blottings).
- Ability to incorporate
in-vitro studies information with in-vivo pharmacokinetic data.
- Assay development
and analytical skills would be a plus.
- Effective oral and
written communication skills in a project-driven environment are essential.
- Supervisory experience.
Biogen Idec
Biogen Idec (HQ in Cambridge, MA) is one of the fastest growing biotechnology companies in the world and a market leader in oncology, neurology, and immunology. We are currently expanding our small molecule programs to match our strong presence in biologics. We lead the search for new treatments that make it possible for patients in more than 90 countries to move closer to the life they want. Biogen Idec's contributions have twice been acknowledged by the Nobel Prize Committee.
Role Description & Responsibilities
We are currently looking for
an experienced DMPK scientist to join a growing, dynamic Discovery DMPK
team within our Drug Metabolism and Pharmacokinetics department.
The incumbent will be responsible for conducting in-vitro and in vivo
absorption studies addressing issues related to GI absorption, transporter
mediated hepatic and renal uptake and efflux, brain penetration and
drug drug interactions. Further, this person will be expected
to incorporate this information with in-vivo pharmacokinetic data. The
incumbent is also responsible for generating and monitoring technologies
within the DMPK department to keep abreast of new scientific developments.
The incumbent will represent DMPK on cross-functional discovery project
teams.
The position reports to the Head of the Discovery DMPK team. The incumbent is expected to build a drug absorption and transporter team and effectively supervise direct reports.
Requirements
- Ph.D. or equivalent
in Biochemistry, Pharmaceutical Chemistry, Pharmacy, or a related science
;
- 5+ years of relevant
industry experience;
- Up-to-date knowledge
of drug transporters and metabolizing enzymes. Knowledge of drug
metabolism, enzyme kinetics, pharmacokinetics, and molecular biology;
- Experience in conducting
in-vitro absorption and transporter studies using cell-based and cell
free models to address intestinal absorption, hepatic and renal uptake
and efflux, blood brain barrier issues as well as determine potential
for drug interactions;
- Experience in cell
culture, cellular and molecular biology related techniques (e.g. western
and northern blottings);
- Ability to incorporate
in-vitro studies information with in-vivo pharmacokinetic data;
- Assay development
and analytical skills would be a plus;
- Effective oral and
written communication skills in a project-driven environment are essential;
- Supervisory experience.
The DMPK and Pharmaceutics department at Genzyme Drug and Biomaterial R&D
is seeking a Staff Scientist. In this role, the candidate will be
responsible for the development and implementation of a cell-based
permeability assay. The candidate will be dedicated to operation of this
protocol including cell culturing, permeability assay, analysis, data
processing and interpretation. The ability to effectively contribute both
individually and in a team setting is essential. The successful candidate
will have strong communication, interpersonal skills, and ability to work
in a challenging and fast-growing environment.
Requirements:
A Ph.D. in pharmaceutical science, biochemistry or related field with at
least 1 year of relevant industrial experience within a DMPK function is
required. Alternatively a BS/MS level with 8+ years of experience would be
considered. Experience with cell-based permeability models (CACO-2/MDCK)
and analysis by LC-MS/MS is essential.
Interested candidates should apply through the website:
www.genzyme.com/careers Reference ID 10611
Merck Research Laboratories (MRL), a world leader in creative and innovative pharmaceutical research to produce novel medicines, is recruiting talented and motivated scientists to join its Drug Metabolism and Pharmacokinetics (DMPK) group in Boston, MA. The group conducts concept-oriented, mechanistic drug metabolism and pharmacokinetic studies to support drug discovery and development goals of MRL. A BS/MS degree in chemistry, pharmacology, biochemistry or a related field with a minimum of 3 years of experience is required, preferably in a DMPK setting. Candidates will conduct quantitative and qualitative discovery stage drug metabolism studies to evaluate pharmacokinetics, biotransformation and metabolic pathway characterization in support of MRL Boston Oncology and Neuroscience projects. In addition, the associate scientist will assist in the management of DMPK laboratory resources, infrastructure and instrumentation, including maintenance and troubleshooting of mass spectrometers and associated instruments. The successful candidate should possess knowledge and skills in one or more of the following areas: pharmacokinetics, in vitro or in vivo metabolism, bioanalytical chemistry, separation technologies, and mass spectrometry. Excellent written and oral communication skills required to work in a highly interactive environment. We offer an excellent salary and comprehensive benefit package including tuition reimbursement and one of the best 401(k) plans in the nation, as well as opportunities for professional growth. For consideration please visit www.merck.com/careers, go to the job code (CHE001214), fill out a profile and attach your resume.
The DMPK and Pharmaceutics department at Genzyme Drug and Biomaterial R&D
is seeking a Staff Scientist. In this role, the candidate will be
responsible for the development and implementation of a cell-based
permeability assay. The candidate will be dedicated to operation of this
protocol including cell culturing, permeability assay, analysis, data
processing and interpretation. The ability to effectively contribute both
individually and in a team setting is essential. The successful candidate
will have strong communication, interpersonal skills, and ability to work
in a challenging and fast-growing environment.
Requirements:
A Ph.D. in pharmaceutical science, biochemistry or related field with at
least 1 year of relevant industrial experience within a DMPK function is
required. Alternatively a BS/MS level with 8+ years of experience would be
considered. Experience with cell-based permeability models (CACO-2/MDCK)
and analysis by LC-MS/MS is essential.
Interested candidates should apply through the website:
www.genzyme.com/careers Reference ID 10611
Avila Therapeutics, Inc., based in Waltham, MA, is a venture-backed, early-stage, life sciences company formed around a unique and proprietary chemistry seeks a Director of Bioanalytical Research. Interested candidates should email: job_opportunities@avilatx.com
Scope:
- Establish Avila Therapeutics’ bioanalytical infrastructure including large molecule (protein), small molecule, DMPK capabilities, and support of biomarker programs
- Develop and utilize protein analytical technologies to characterize potential drug targets and enable understanding of small molecule drug mechanism of action
- Establish small molecule bioanalytical capabilities to characterize lead compound DMPK properties
- Design, execute and interpret analytical pharmacology experiments to support the entire Avila Therapeutics drug discovery and development continuum
- Participate in the strategic management of the Avila Therapeutics small molecule portfolio
- Establish relationships with external proteomics collaborators and consultants
Requirements:
- Ph.D. in the area of analytical chemistry, biochemistry, or protein chemistry with 4-8 years industrial experience in applying analytical methods to drug discovery
- Proven expertise and experience in building a bioanalytical lab
- Extensive experience in advanced mass spectrometry (MALDI- and SELDI- TOF/TOF and LC-MS/MS)
- In-depth knowledge and hands-on experience with multiple mass spectrometry platforms (e.g.: ion trap, triple-quad, and ion trap-FT)
- Expertise in database searching for peptide identification using Mascot, Seaquest, Spectrum Mill, and other software
- Demonstrated research track record in protein and organic small molecule bioanalytical research
- Highly collaborative, self-motivated, team-oriented, and have excellent communication and computer skills
- Ability to work in a fast paced, highly integrated team environment where accuracy, accountability and timeliness is essential
- Excellent oral and written communication skills
sought to provide study design and pharmacokinetic data analysis support for all programs in preclinical and clinical development. Essential job duties include, but are not limited to:
Conduct pharmacokinetic analyses, modeling & simulations including pharmacokinetic (PK) and pharmacodynamic (PD) modeling, allometric scaling, and dose estimation assessments for first in human studies.
Design pharmacokinetic/toxicokinetic studies and support oversight of in-life activities at contract research organizations (CROs).
Attend project team meetings on an as needed basis and provide expert PK input .
Review protocols, prepare study reports, prepare pharmacokinetic sections for regulatory submissions, internal project summaries, reviews etc.
Present data to management and project teams.
Key skills and competencies: Demonstrated experience with the design, conduct and analysis of data from PK studies; PK/PD experience with protein therapeutics is required. Experience (expert user level) using WinNonlin software is required. Direct experience with PK-PD modeling, including allometric scaling, as well as experience in estimating first-in human safe doses of protein-based therapeutics. Experience using additional advanced PK modeling software. Knowledge and actual experience in the GLP laboratory environment is required. Excellent inter-personal skills. Leadership Capabilities: Demonstrated experience leading small groups is a plus.
Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers. To learn more or apply to the position, please email Kelley Boutin at kboutin-c@shire.com.
We seek a self-motivated Senior Scientist/Group Leader to support targeted anticancer drug discovery and development programs. Our Pharmaceutical client would like this person to come in and build a small group (2-4 people). It's an exciting time, as they are really restructuring and building up with some old resources and many new. So, this person will have a good opportunity to be a part of that, and to help shape things. As part of our discovery team, the qualified person will be responsible for: Hands-on contributor work in charge of building and leading DM/PK group; Design, execution, and interpretation of in vitro and in vivo drug metabolism and PK studies; Work closely with Oncology group for PK/PD modeling and simulation to assist drug candidate identification, optimize study design, and expedite clinical drug development; and Participate in the preparation of IND filings. Requirements for this position include: Ph.D. in Pharmaceutical Sciences or Pharmacology with a minimum of 5 years experience in drug discovery research; In-depth knowledge of and hands-on experience with pharmacokinetics, drug metabolism, and PK/PD modeling and simulation; and Strong communication and interpersonal skills necessary to deliver scientific presentations.
Candidates should contact Joe Freddolino, Prestige Scientific, 1 Maple Street, 4th Floor, Milford, MA 01757; Phone: 508-422-9322 Ext. 11; Fax: 508-422-9339; Mobile: 617-799-9942; email jfreddolino@prestigescientific.com
is sought by Idenix Pharmaceuticals. Responsibilities for this position will be: Develop quantitative analytical methods for biological matrices in support of pharmacokinetic studies in various stages of drug discovery and development. Provide general analytical support for pharmacokinetic and metabolism studies. Establish LCMS assays for in vitro metabolism and train new users. Work in a team environment where timely delivery is essential. Plan, manage and supervise outsourcing activities during bioanalytical method transfer, method validation and sample analysis in GLP studies to ensure quality and adherence to timelines. Ensure that regulated studies are in compliance with GLP/FDA/ICH guidelines. Develop suitable procedures to facilitate bioanalytical work in-house. Write and review analytical protocols and reports. Readily adjust plans to changes made in project priorities. Required Education/Experience: PhD or Masters degree in analytical chemistry and more than 5 years of experience from pharmaceutical industry. Strong skills in separation science and quantitation of small molecules using LC-MS/MS. Extensive experience in biological sample analysis and different sample extraction techniques. Profound knowledge in GLP and regulatory guidelines for bioanalysis, strong problem solver and good report writing and communication skills. Idenix offers an excellent benefits package including competitive salary, equity compensation, major medical insurance, dental insurance, 401(k) plan participation, and group life and disability insurance. To be considered for this position, please send your resume by email to hr@idenix.com, or by mail to: Human Resources, Idenix Pharmaceuticals, 60 Hampshire Street, Cambridge, MA 02139 . Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus. For further information about Idenix, please refer to www.idenix.com.
This individual will be part of a team providing drug metabolism and pharmacokinetic information for Genzyme’s small molecule drug discovery and development programs. The candidate will be responsible for the development and qualification of methods to quantitate new chemical entities and their metabolites to support in vitro and in vivo drug metabolism and pharmacokinetic studies. Techniques used will include LC-MS/MS and automated approaches to higher throughput. The individual will be responsible for the quality and interpretation of their data, and for ensuring timely documentation and communication of results.
Requirements:
A BS/MS in analytical chemistry, pharmaceutical sciences or related field with 5+ years of industrial experience within a DMPK function is required. Experience in LC-MS/MS and automation is also required.
Desired:
The ability to effectively contribute both individually and in a team setting is essential. The successful candidate will have strong communication, interpersonal skills, and ability to work in a challenging and fast-growing environment. Experience in a GLP working environment will be a plus.
Contact: Hanlan Liu, DMPK & Pharmaceutics Department, Drug and Biomaterial R&D, Genzyme Corporation, 153 2nd Avenue
Waltham, MA 02451, Email: Hanlan.Liu@genzyme.com
is sought by a Cambridge based pharmaceutical company, to manage preclinical aspects of development projects, with particular focus on ADMET/DMPK, through management of internal and external activities. RESPONSIBILITIES include all or some of the following: Manage preclinical development projects as assigned, resulting in projects being completed on time and with objectives achieved. Manage ADMET/DMPK studies, both nonclinical and in support of clinical studies. Manage nonclinical pharmacology and/or drug safety studies. Manage scientific studies, both internal and external. Write/revise preclinical sections of INDs or equivalent and technical reports for effective reader acceptance. Supervise staff as required. EDUCATION / SKILL / EXPERIENCE REQUIREMENTS: Ph.D. in pharmaceutical development-relevant field (or equivalent experience); Demonstrated problem-solving, organizational and communication skills; At least 5 years experience in industrial pharmaceutical development, particularly in ADMET/DMPK; Experience in development of parenteral drugs required (experience in development of oral drugs desirable); Excellent technical writing ability. Candidates should contact Joe Freddolino, Prestige Executive Search Corp., 89 Main St., 4th Floor, Milford, MA 01757; Phone: 508-422-9322 Ext. 11; Fax: 508-422-9339; Mobile: 617-799-9942; email jfreddolino@prestigeesc.com
To apply, please send CV and cover letter to JOB.RBAP@microbia.com
Microbia, Inc. is seeking a talented, highly motivated pharmacokineticist with analytical experience to join our Analytical Pharmacology / DMPK group. The successful applicant will become part of cross-functional drug development and discovery teams in support of Microbia's therapeutic pipeline. RESPONSIBILITIES: Development, qualification and use of LC/MS/MS bioanalytical methods for multiple development programs; analysis of pharmacokinetic and toxicokinetic data using validated PK software; provide nonclinical PK/bioanalytical expertise on multifunctional clinical development teams as well as drug discovery teams; management of outsourced GLP analytical studies, evaluation and auditing of contract research labs, facilitating method transfer, and reviewing GLP validation reports; supervise and mentor research associates; report writing for IND submissions and related documents. QUALIFICATIONS: BS/MS with 10+ years experience or a PhD with at least 5 years relevant experience in analytical chemistry, pharmacology or equivalent; Experience with bioanalytical study monitoring under GLP conditions; experience using HPLC and MS techniques; practical experience interpreting PK studies and using WinNonlin or other PK analysis tools; ability to write, edit and coordinate reports for regulatory submissions and business development meetings; familiarity with allometric scaling and PK/PD modeling experience is a plus.
To apply, please send CV and cover letter to JOB.JWRA@microbia.com
Microbia, Inc. is seeking a talented, highly motivated research associate to join the Analytical Pharmacology / DMPK group to meet a variety of analytical challenges. The successful applicant will become part of cross-functional drug discovery teams in support of Microbia's therapeutic pipeline. RESPONSIBILITIES: Perform a variety of in vitro ADME studies that will include enzymatic and cell-based assays, protein binding and cell culture and in vitro to support drug discovery projects; development of HPLC and LC/MS methods used in metabolite profiling; perform quantitative LC/MS/MS for quantitative bioanalysis used in pharmacokinetic studies; clearly communicate and present results in a collaborative multi-functional environment. QUALIFICATIONS: BS/MS in biochemistry, analytical chemistry or pharmacology with at least a year of industrial experience is required; practical experience performing in vitro ADME assays is highly desired; Experience with HPLC, LC/MS/MS and other analytical instrumentation is a plus; excellent written and oral communication skills with an attention to detail.
To apply, please send CV and cover letter to JOB.MKAB@microbia.com
Microbia is seeking a talented, highly motivated biochemist to join the Analytical Pharmacology / DMPK group to meet a variety of analytical challenges. The successful applicant will become part of cross-functional drug discovery teams in support of Microbia's therapeutic pipeline. RESPONSIBILITIES: To advance our drug leads you will use a variety of analytical biochemistry techniques that will include: ELISA, 2D gel electrophoresis, enzyme-linked and radio-immunoassays, enzyme and whole-cell assays, a wide variety of spectroscopic techniques, HPLC and LC/MS; purify and characterize important enzymes involved in metabolism or drug targets as well as develop new binding or activity assays; design, direct and complete research projects; represent the Analytical Pharmacology / DMPK function on drug discovery teams; report writing for IND submissions and related documents; presentations at internal and external meetings.
QUALIFICATIONS: Ph.D, in enzymology, chemistry/biochemistry, pharmacology or a related field; industrial laboratory experience with emphasis on protein chemistry and experience in a variety of analytical biochemistry techniques, including HPLC; experience in drug metabolism highly desired; LC/MS or proteomics experience is a plus; experience with report and manuscript writing with an attention to detail; excellent presentation and oral communication skills.
Cytokenetics is currently seeking an Associate Director or Director level individual to lead our DMPK/Bioanalytical team. Qualifications: Ph. D. with 7+ years of industry experience in pharmacokinetics and drug metabolism. Demonstrated record of excellence in leadership and management of DMPK/Bioanalytical scientists and associates. Strong expertise in all DMPK concepts (i.e., preclinical pharmacokinetics, PK/PD relationships, metabolism, bioanalysis, toxicokinetics and in vitro and in vivo techniques applying to these concepts). Excellent interpersonal, communication, and decision-making skills. Demonstrated ability to inspire and lead scientists and associates. Demonstrated ability to manage external contractors to meet/exceed Company goals. Must have strong negotiating skills and business-oriented. Well organized and computer-literate. Now is the perfect time for you to consider a move to Cytokinetics where you can put all of your skills to maximum use. You will enjoy a truly unique culture as well as a competitive benefits program. Interested applicants, please visit the Cytokinetics website at: www.cytokinetics.com. Cytokinetics is an Equal Opportunity Employer.
Responsible for non-clinical PK/TK and related ADME studies on both small molecules and biologics to support early and late stage programs. Duties will include study design, oversight of CRO study phase, & analyses and reporting of the data. Will interact with toxicologists, discovery and clinical scientists and regulatory representatives to develop and execute development strategy for drug candidates. Will participate on cross-functional project teams, provide functional input, lead and support plans according to project timelines and priorities. Will be in charge of writing relevant regulatory documents, and interaction with regulatory authorities. Requirements: PhD in Pharmacokinetics, Pharmacology or Pharmaceutical Sciences with 5+ years of experience. Experience using PK modeling software such as WinNonlin, WinNonmix, or NonMem is essential. Thorough understanding and current knowledge of ADME principles and interspecies scaling. Seeking the ability to incorporate in-vitro ADME studies information with in-vivo PK data. Experience with regulatory submissions and managing multiple projects is sought. Excellent oral & written communication and interpersonal skills are essential. Apply for this position via the Biogenidec website (use keyword 3942BR).
Archemix is seeking an RA who will be responsible for investigating ADME characteristics of Oligonucleotides based drug molecules and biopharmaceutical analysis utilizing HPLC, CGE and LC/MS/MS methods in support of drug discovery and development programs. A successful person in this position will conduct in vitro and in vivo ADME studies, develop and validate bioanalytical methods, and conduct routine drug analysis in biological matrices. This involves the design, implementation, data analysis and reporting of in vitro and in vivo experiments to acquire drug absorption, metabolism, distribution, and elimination information. Additionally, will develop and apply appropriate analytical methodologies to measure drug and metabolite concentrations. Responsibilities will also include routine instrument maintenance and troubleshooting. Requires a B.S. /B.A/MS. in analytical chemistry, pharmaceutical sciences, biochemistry/molecular biology or a related field with 2 to 3 years relevant experience in ADME, bioseparation and analytical instrumentation. Experience and training in pharmacokinetics and biochemical drug metabolism, PK data analyses, HPLC, LCMS, CGE and metabolite structure elucidation is desired. Candidates must be highly motivated and organized with excellent communication skills (both oral and written). Other skills include being observant and detail oriented with the ability to multitask and thrive within a team. We are located in Kendall Square (Archemix Corporation, 300 Third Street, Cambridge, MA 02142; www.archemix.com) at the center of the nation’s biotech hub. We offer an exceptional compensation package, which includes competitive salaries and stock options, and a rich benefits package. Please forward an electronic CV including references to careers@archemix.com.
Archemix is seeking a candidate who can work independently as the study director of ADME-styled In Vivo studies. Responsibilities include to plan, design, organize, participate in, interpret, and report data to determine the In Vivo metabolic and pharmacokinetic disposition of development compounds. Typical studies include both rodent and non-rodent metabolism, recovery of administered isotope-dose, excretion profile/routes, isotope-label in vivo stability, and single-dose pharmacokinetics. Additional tasks include developing and modifying research methods and techniques to address specific issues and questions. Interaction with scientific staff to ensure experimental protocols are followed, relevant observations are communicated to management/supervisor accurately, and scientific integrity of results is maintained. In addition to writing of reports and study summaries following study completion participate in the oral presentation of study results at departmental and/or interdisciplinary meetings. This person will provide direction and training to junior scientists and RAs, and provide and implement strategies and tactics to enable programs to select drug candidates for nomination into development. Also, overseeing administrative aspects associated with ordinary laboratory functions, which includes the writing of Standard Operating Procedures (SOPs). PhD degree required in Pharmacokinetics, Drug Metabolism, Pharmacology or Pharmaceutical Sciences. Excellent knowledge in pharmacokinetic principles and drug metabolism is a must with working knowledge of ADME/PK science as related to drug discovery, drug delivery or general disposition is highly desirable. Experience in pharmacokinetic data analysis including pharmacokinetic modeling, simulation and prediction and Pharmacokinetic and Pharmacodynamic data analysis is a must. The candidate must be familiar with laboratory techniques such as In Vitro and In Vivo metabolism and pharmacokinetic experiments, analysis of drugs and metabolites in biological fluids. The candidate must have working experience and proficiency with HPLC and LCMS instruments. Skill sets include being highly motivated and having excellent written and oral communication skills and interpersonal skills, and the ability to interact in a matrix team environment, and be observant and detail oriented with the ability to multitask. We are located in Kendall Square (Archemix Corporation, 300 Third Street, Cambridge, MA 02142; www.archemix.com) at the center of the nation’s biotech hub. We offer an exceptional compensation package, which includes competitive salaries and stock options, and a rich benefits package. Please forward an electronic CV including references to careers@archemix.com.