CAREERS
NEDMDG WELCOMES LISTINGS OF JOB OPENINGS IN RELEVANT AREAS – DRUG METABOLISM, PHARMACOKINETICS, ADME STUDIES ETC.
PLEASE SEND SUBMISSIONS TO SECRETARY@NEDMDG.ORG
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Scientist II or III - Metabolite Profiling, Boehringer Ingelheim Pharmaceuticals Inc.
Company: Boehringer Ingelheim Pharmaceuticals Inc.
Location: Ridgefield, CT
Job Description: Scientist II or III
Click link to apply: Job Description – Scientist II or III LCMS (2214746) (taleo.net)
Description:
Boehringer Ingelheim is seeking a highly motivated LCMS Scientist II or Scientist III to join the Drug Metabolism & Pharmacokinetics (DMPK) department at our US headquarters in Ridgefield, CT. Relocation Package Available.
As a Scientist II or III, you will be responsible for conducting metabolite profiling and structural elucidation experiments in support of our small molecule development candidates. You will be responsible for analyzing radioactive samples (plasma, excreta) from preclinical species and humans utilizing liquid chromatography-high resolution mass spectrometry. Active and productive collaboration with other scientists within the department is expected.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
Duties & Responsibilities:
- Conduct metabolite identification experiments with minimal supervision using in vitro, preclinical, and clinical samples
- Operate liquid chromatography-high resolution accurate mass spectrometry instrumentation
- Clearly communicate results through oral presentations and written documentation
- Comply with applicable regulations, perform all work in a safe and responsible manner, and maintain proper records in accordance with SOPs and corporate policies
Scientist II Requirements:
- Bachelor’s degree in chemistry, biochemistry, chemical engineering, or other relevant field from an accredited institution with three or more years of pharmaceutical industry experience
- Master’s degree in chemistry, biochemistry, chemical engineering, or other relevant field from an accredited institution
- Laboratory experience should include familiarity with LC-MS systems and related technology
- Familiarity with general principles of small molecule biotransformation is considered beneficial
- Must be comfortable with the safe and appropriate use of radioactivity; prior experience preferred
- Effective oral and written communication skills are essential
Scientist III Requirements:
- Bachelor’s degree in chemistry, biochemistry, chemical engineering, or other relevant field from an accredited institution with seven or more years of pharmaceutical industry experience
- Master’s degree in chemistry, biochemistry, chemical engineering, or other relevant field from an accredited institution with three or more years of pharmaceutical industry experience
- Laboratory experience should include proficiency with LC-MS systems in an industrial setting related to biotransformation pathways of investigational compounds
- Proficiency with general principles of small molecule biotransformation and structure elucidation, including an understanding of enzymology as applied to drug metabolism
- Must be comfortable with the safe and appropriate use of radioactivity; prior experience preferred
- Effective oral and written communication skills are essential
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Who We Are:
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Job
– Research & Development
Primary Location
– Americas-US-CT-Ridgefield
Organization
– US-BI Pharma/BI USA
Schedule
– Full-time
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Senior Scientist/Associate Director, DMPK, Boston Pharmaceuticals, Inc.
Company: Boston Pharmaceuticals, Inc.
Location: Cambridge, MA
Job Description: Senior Scientist/Associate Director
Position Overview
The Senior Scientist/Associate Director of DMPK will establish and oversee the execution of pre-clinical and clinical drug metabolism and pharmacokinetics strategies for small molecules, biologics, and other non-small molecule modalities programs within the Boston Pharmaceuticals pipeline. The person in this role will be a part of the Translational Research team and report to the Head of Drug Metabolism and Pharmacokinetics. He/She will be the part of the non-clinical and clinical program teams within Boston Pharmaceuticals (BP) and guide the teams with program strategy and input into non-clinical and clinical studies, incorporating DMPK strategies into documents such as trial protocols, ICFs, sample collection protocols, and lab manuals. He/She will also manage external contract research organizations (CROs) to enable implementation of DMPK studies for biologics and non-small molecule programs. The level of hire will be determined by candidate capabilities and experience. The successful candidate must have a “hands-on” approach for supporting Boston Pharmaceutical pipeline while partnering closely with cross-functional leadership to ensure scientific and executional excellence.
Key Responsibilities:
- As a member of the non-clinical and clinical project teams develop strategies for program support and guide the teams in execution of the DMPK, clinical pharmacology, and global program strategies.
- Serve as a leading internal expert on drug metabolism, pharmacokinetics, non-compartmental and compartmental PK analysis, modeling and simulation; and guide project teams on the timing and appropriateness of specific studies to support clinical and non-clinical development of BP programs.
- Provide input into non-clinical and clinical studies, incorporating DMPK and clinical pharmacology strategies into documents such as trial protocols, ICFs, sample collection protocols, and lab manuals.
- Manage external alliances and partnerships including contractors and consultants to develop and execute DMPK and Clinical Pharmacology strategies. As necessary, initiate studies with CROs by interfacing with Translational Research, Clinical, Finance, and Strategic Sourcing groups and ensure qualification of new CRO labs by working with BP compliance leads.
- Partner with project toxicologists, pharmacologists, and clinical leads to assure timely support of clinical and non-clinical studies and appropriate communication of results to shape timely decision making.
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- Present summary data to project teams and Boston Pharmaceuticals senior leadership
- Assure accuracy, and author when appropriate, sections of various regulatory documents (for example, pre-IND briefing documents, INDs, IBs) and ensure their regulatory compliance.
- Play a supporting role in all business development discussions (in-licensing and out-licensing) across the portfolio.
Required Qualifications:
- MS with 7+ years or PhD with 3+ years (Senior Scientist position) and 7+ years (Associate Director position) of relevant pharmaceutical/large biotech Industry experience.
- Requires a thorough understanding of DMPK and Clinical Pharmacology principles in drug development, including:
-
- Hand-on experience with PK analysis with WinNonlin and other relevant software,
- Understanding of PB/PK and PK/PD modeling to support
- starting human dose prediction utilizing pharmacology and toxicology data
- dose selection for pivotal phase II and III studies
- Understand the basic biology of the intended target and mechanisms of action of drug candidates to develop a rational DMPK/Clinical Pharmacology plan.
- Experience in supporting project teams as a DMPK/Clinical Pharmacology expert representative.
- Proven experience in managing external alliances and partnerships.
- Proven ability to perform successfully under stringent timelines and with changing and competing priorities.
- Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.
- Prior experience on thriving in a small/entrepreneurial setting is preferred.
How to apply:
Interested candidates can send their CV to:
Swapan Chowdhury
Head, DMPK at Boston Pharmaceuticals
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DMPK Preclinical Modeler - Senior/Principal Scientist, Schrödinger
Company: Schrödinger
Location: New York
Job Description: DMPK Preclinical Modeler – Senior/Principal Scientist
Company Overview
We’re seeking a Preclinical Modeler to join us in our mission to improve human health and quality of life as part of our drug discovery group by contributing to our rapidly expanding portfolio of drug discovery programs and collaborations.
Our drug discovery and early clinical development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers, as well as a large-scale compute infrastructure to apply our proprietary physics-based drug design and optimization platform. Ten of the programs we’ve worked on have progressed into preclinical development, with nine currently in clinical trials and one approved by the FDA.
Who will love this job:
- A PK, PK/PD, and PBPK modeling expert
- A DMPK scientist who is also an experienced user of PK/PD and PBPK modeling software, such as Phoenix/WinNonlin Simcyp, Monolix, and MATLAB/SimBiology, or other equivalent software
- A highly motivated, self-driven, and results-oriented data-analyzer
- An excellent communicator and presenter who can work both as a team player and a project driver
- A flexible, socially adept scientist who’s excited about networking and building internal and external relationships
What you will do:
- Develop and drive PBPK and PK/PD strategies for Drug Discovery and Development projects
- Appropriately apply PK, PK/PD and PBPK modeling/simulation to guide the design and execution of in vivo preclinical animal experiments for efficacy and toxicology, establish human dose predictions and develop robust translational and biomarker strategies for clinical candidates
- Collaborate with internal and intercompany project team members and external CROs to generate relevant data to enable knowledge and data integration
- Effectively communicate PK. PK/PD, and PBPK knowledge and strategy to internal and intercompany project teams, functional leaders, and other key stakeholders
- Author and/or review appropriate reports for regulatory submission of development drug candidates and ensure the overall quality of the studies and interpretation. Support interactions with regulatory agencies.
What you should have:
- PhD in life sciences, chemical engineering, pharmacokinetics, pharmaceutical sciences, or a related discipline, with strong focus on mathematical modeling
- Prior experience (5-10 years preferred) conducting PK/PD and PBPK modeling in support of drug discovery and development
- Ability to collaborate and develop strong working relationships to resolve issues and advance programs
- Working knowledge of PBPK and familiarity with modeling software such as Simcyp, GastroPlus, MatLab/Simbiology, Monolix, and/or Phoenix WinNonlin, or other equivalent modeling software
- Prior experience with independently representing DMPK on project teams is a plus
- Excellent collaborative and communication skills
Pay and perks:
Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain’s New York Best Places to Work for the past three years running.
Estimated base salary range (NYC only): $135,000 – $175,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
Sound exciting? Apply today and join us!
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company’s mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, “diversity” isn’t just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn’t mean better headlines or public images – it means increased adaptability and profitability.
How to apply:
Apply through Job page link below:
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DMPK Senior/Principal Scientist, Schrödinger
Company: Schrödinger
Location: New York
Job Description: DMPK Senior/Principal Scientist
Company Overview
We’re seeking a DMPK Scientist to join us in our mission to improve human health and quality of life as part of our drug discovery group by contributing to our rapidly expanding portfolio of drug discovery programs and collaborations.
Our drug discovery and early clinical development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers, as well as a large-scale compute infrastructure to apply our proprietary physics-based drug design and optimization platform. Ten of the programs we’ve worked on have progressed into preclinical development, with nine currently in clinical trials and one approved by the FDA.
Who will love this job:
- A DMPK analysis expert, with a strong understanding of the principles of ADME and its applications throughout drug development
- A DMPK expert with good understanding and application of the principles governing Good Laboratory Practices (GLP)
- A scientist with good understanding of the use and application of PK/PD and PBPK modeling approaches to optimize compound selection, dose optimization, and study design
- A DMPK scientist with experience in the use of commonly used PK/PD software, such as Phoenix/WinNonlin Simcyp, Monolix, and MATLAB SimBiology, or other equivalent software
- A proven PI and scientific strategist
- A highly motivated, self-driven, and results-oriented data-analyzer
- An excellent communicator and presenter who can work both as a team player and a project driver
- A flexible, socially adept scientist who’s excited about networking and building internal and external relationships
What you will do:
- Develop and drive DMPK and PK/PD strategy for Drug Discovery and Development projects
- Represent DMPK group on internal and intercompany project teams to provide input on molecular modeling design ideas into druggable novel chemical entities
- Collaborate with internal and intercompany project team members and external CROs to generate relevant data to enable knowledge and data integration
- Effectively communicate DMPK and PK/PD knowledge and strategy to internal and intercompany project teams, functional leaders, and other key stakeholders
- Analyze and integrate in silico ADME predictive solutions, physicochemical, ADME, and DMPK data to impact multiparameter optimization
- Author and/or review appropriate reports for regulatory submission of development drug candidates and ensure the overall quality of the studies and interpretation. Support interactions with regulatory agencies.
What you should have:
- PhD in life sciences, chemical engineering, pharmacokinetics, pharmaceutical sciences, or a related discipline
- 5-10 years (preferred) experience working with DMPK in the pharmaceutical industry.
- Prior experience independently representing DMPK on project teams
- Working knowledge of PBPK and familiarity with modeling software such as Simcyp, GastroPlus, MatLab/Simbiology, Monolix, and/or Phoenix WinNonlin, or other equivalent modeling software. Hands-on experience in developing PK/PD and PBPK models as applied to drug development is a plus
- Previous experience, or familiarity with the principles governing Good Laboratory Practices (GLP)
- Ability to collaborate and develop strong working relationships to resolve issues and advance programs
- Excellent collaborative and communication skills
Pay and perks:
Schrödinger understands it’s people that make a company great. Because of this, we’re prepared to offer a competitive salary, stock options, and a wide range of benefits that include healthcare (with dental and vision), a 401k, pre-tax commuter benefits, a flexible work schedule, and a parental leave program. We have catered meals in the office every day, a company culture that is relaxed but engaged, and over a month of paid vacation time. Our Administrative and Human Resources departments also plan a myriad of fun company-wide events. New York is home to our largest office, but we have teams all over the world. Schrödinger is honored to have been selected as one of Crain’s New York Best Places to Work for the past three years running.
Estimated base salary range (NYC only): $135,000 – $175,000. Actual compensation package is dependent on a number of factors, including, for example, experience, education, degrees held, market data, and business needs. If you have any questions regarding the compensation for this role, do not hesitate to reach out to a member of our Strategic Growth team.
Sound exciting? Apply today and join us!
As an equal opportunity employer, Schrödinger hires outstanding individuals into every position in the company. People who work with us have a high degree of engagement, a commitment to working effectively in teams, and a passion for the company’s mission. We place the highest value on creating a safe environment where our employees can grow and contribute, and refuse to discriminate on the basis of race, color, religious belief, sex, age, disability, national origin, alienage or citizenship status, marital status, partnership status, caregiver status, sexual and reproductive health decisions, gender identity or expression, sexual orientation, or any other protected characteristic. To us, “diversity” isn’t just a buzzword, but an important element of our core principles and key business practices. We believe that diverse companies innovate better and think more creatively than homogenous ones because they take into account a wide range of viewpoints. For us, greater diversity doesn’t mean better headlines or public images – it means increased adaptability and profitability.
How to apply:
Apply through Job page link below:
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Scientific Director ADME - Novel Modalities, Research & Development, Eli Lilly
Company: Eli Lilly
Location: Cambridge, MA
Job Description: Scientific Director ADME – Novel Modalities
Company Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
Do you possess a unique passion for the science of drug discovery and development? Our diverse ADME team is seeking a hardworking scientist experienced in the discovery and clinical development of biological therapeutics including peptides, fusion proteins, mAbs, RNAs and oligonucleotides. If you have a talent for finding creative solutions to complex problems, apply today! We want you on our team.
We are a scientifically agile team comprised of dedicated scientists who work to deliver novel biological therapies to patients. We support one another through shared-learning and mutual-responsibility for the enterprise of making medicines. Ours is a flexible environment where each team member can optimize their productivity while being mindful of wellness. This enables each of us to grow our careers as well as the scientific field in our search for safe and effective medicines. Please connect with us if you are a motivated and collaborative scientist looking for an opportunity to innovate at the forefront of novel biotherapies to improve the lives of patients.
A high-quality candidate will demonstrate the following:
- Keen ability to derive and efficiently test ADME and DMPK hypotheses to inform decisions that drive multi-parametric structural optimization.
- Detailed knowledge of contemporary regulatory guidance’s and expectations including those pertaining to NDA and BLA submissions.
- Strong working-knowledge in fundamental pharmaceutics, pharmacokinetics and ADME principles as it pertains to biological therapeutics.
- Skills to integrate internal and external laboratory and other experimental resources through high quality scientific associations.
- Agile interrogation of diverse data streams (e.g., in silico, in vitro, in vivo) to derive mechanistic understanding of drug action and performance characteristics.
- Experience in effectively collaborating with key partners including toxicology, clinical pharmacology, discovery biology, therapeutic area specialists, protein engineering, and diverse regulatory agencies in a coordinated effort to advance programs to and through clinical testing.
Lilly-ADME seeks a skilled, experienced ADME scientist who will:
- Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly portfolio.
- Design and implement hypothesis driven studies to answer ADME-PK, PK/PD and toxicokinetic (TK) questions.
- Integrate ADME, PK and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide protein engineering and drug delivery and optimization strategies.
- Effectively engage, innovate and collaborate with colleagues and interdisciplinary teams.
- Critically evaluate integrated data packages and in due diligence of assets for developability assessment.
- Lead the preparation of regulatory communication and documents to support clinical development, new drugs applications and line extensions and interact with regulatory agencies worldwide.
- Build and foster relationships through coaching and mentorship with fellow scientists.
- Possess excellent written and verbal technical communication and the demonstrated ability to lead, guide and influence teams in decision making.
Basic Requirements
Ph.D. in Biochemistry/Biology/Cell Biology/Pharmacokinetics or a related scientific field and 5+ years of experience in the industrial discovery and development of biological therapeutics.
Additional Skills/Preferences
- Industry (pharma, biotech, etc.) experience with PK/PD modeling of bio-therapeutics.
- Understanding of and experience with immunoassay and/or LC/MS bioanalytical methodology.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
How to apply:
Apply through Job page link below:
https://careers.lilly.com/us/en/job/R-39973/Scientific-Director-ADME-Novel-Modalities
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Director, Bioanalysis for B Cell Therapy
Company: Be Biopharma, Inc
Location: Cambridge, MA
Job Description: Director of Bioanalysis for B Cell Therapy
Company Overview
Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. For more information, please visit us at Be.Bio and our LinkedIn page.
The beating heart of Be Bio is our People and together we are building a culture driven by purpose, passion, and that’s full of character. We are “all-in” as we align ourselves with patients who need our medicines, and we embrace the highest standards of transparency, excellence, candor, collaboration, and team-based science with a shared ownership of company milestones and successes.
Our commitment to our team members is to deliver a compelling, dynamic work experience that enables them to continually stretch, grow, and learn, that enriches their lives, that fosters a sense of belonging and community, and that goes above and beyond to support them in big, meaningful ways in both their personal and professional lives. Be Bio is a team that works hard, plays hard, and supports each other on our shared journey to get transformative medicines to patients who need them.
Position Overview:
The Director of Bioanalysis for B Cell Therapy is responsible for building and leading a team of scientists to develop bioanalytical plans and be involved in the design, development, qualification, and validation of quantitative assays supporting B cell therapy research and development. This is an exciting opportunity at Be Bio, which is creating a bold new class of cell therapies and is advancing B cell therapy to clinic.
Job Responsibilities
- Build up our bioanalytical capability to support B cell therapy programs at both research and development stages
- Builds and retains a team of high-performing scientists & RAs that can realize the company’s goals
- Act as the subject matter expert (SME) in protein assays (e.g., LC-MS, ELISA), molecular assays (e.g., qPCR, ddPCR etc.), and cellular assays (e.g., flow cytometry, ELISpot etc.) development, qualification, and validation
- Be involved in the design, development, qualification, and validation of quantitative assays supporting B cell therapy programs from research to clinic.
- Develop internal guidelines for bioanalytical method development and ruggedness evaluation of assay in support of in vivo studies
- Identify CROs, oversee method development in house or at identified CROs, method transfer and method validation at CROs. Ensures bioanalytical method development is performed with a level of rigor and validation appropriate for stage of research and development ensuring compliance with internal guidelines, SOPs and regulatory guidelines.
- Review data for scientific rigor and ensure project compliance with external regulatory requirements and internal guidelines
- Review and approve method qualification/validation reports and sample analysis reports.
- Drive innovation within Bioanalysis and keep up to date of new technologies and instrumentation for implementation of new experimental strategies.
- The ability to deliver clear, concise, and persuasive oral, and written communications is required.
- Key interdepartmental collaborations will include Research, Technical Operation, and Clinical group to ensure adequate and timely bioanalytical support of non-GLP and GLP preclinical and clinical studies.
- Maintain and support safe lab practices and environment.
Experience, Education, Specialized Knowledge, and Skills:
Must thrive in a fast-paced, growing, and innovative environment where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpersonal skills, ability to develop important relationships with your stakeholders, and being an all-around good company citizen are essential. Demonstrated ability to manage a high-performing team where collaboration and innovation are essential.
- Ph.D. or Master’s degree in biology, immunology, chemistry, pharmacology, or related scientific fields required with 10+ years’ relevant experience.
- Demonstrated experience and expertise in developing and establishing bioanalytical methods to support cell and gene therapy programs
- Strong background in protein assays (e.g., LC-MS, ELISA), molecular techniques (qPCR, ddPCR etc.) and cellular assays such as flow cytometry, ELISpot etc.
- Knowledge of current regulatory guidance and industry best practices in cell and gene therapy bioanalysis
- Familiar with requirements of FDA/EMA, GLP/GCLP regulations, and ICH guidelines.
- Great leadership experience in both project and people management is required.
- Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and CROs.
- Ability to work independently and have good attention to the details.
- Background in B cell biology/immunology highly desirable
How to apply:
Apply through Job page link below:
https://boards.greenhouse.io/bebiopharma/jobs/4633509004
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345447BR Novartis Biotransformation Scientist, PK Sciences
Company: Novartis
Location: Cambridge, MA
Job Description: Biotransformation Scientist
Company Overview
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Position Overview:
100,000 + people across 140 countries are working for Novartis to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering, and to enhance the quality of life!
Biotransformation is a key discipline within the Drug Disposition (DD) unit of the Pharmacokinetic Sciences (PKS) department that is essential for the progression of small molecules and new modalities such as drug-protein conjugates, oligonucleotides, peptides and radio-ligands from preclinical discovery into human and up to regulatory filing.
PKS is currently seeking a laboratory-based associate to join the biotransformation team in Cambridge, MA. In this role, you will be joining a large global team of skilled and motivated drug metabolism scientists who closely collaborate with other groups both within and outside of PKS in a highly cross-functional environment.
As the successful candidate you will be adaptable, independently motivated, and challenge driven with a history that demonstrates strong interpersonal skills that encourage successful collaborative working relationships. In this role, you will work in a team environment to support programs through the conduct of drug metabolism studies designed to understand ADME properties, biotransformation pathways, and routes of elimination for a diverse portfolio of therapeutic modalities. Your major responsibilities will include planning, conducting and documenting experiments designed to investigate metabolic pathways and structural elucidation of metabolites formed from new drug candidates using state of the art high resolution mass spectrometers.
PKS offers many opportunities to diversify your skills and develop your career. You will be encouraged to interact with and present your findings to project teams and will be given development opportunities to increase your project management skills including representing the ADME function on project teams and serving as a part-time project team manager.
Job Responsibilities
Your main accountabilities will include:
• Design and execution of biotransformation studies to assess metabolic pathways, soft-spot identification, structural elucidation, and bioactivation of drug candidates
• Organize and prepare experimental protocols and study reports with upload of results to a centralized database
• Presentation of key findings to project teams and/or other stakeholders
• Support discovery, pre-clinical, and clinical development studies (in vitro and in vivo) to aid drug candidate progression
• Assure quality standard guidelines and safe work practices are applied while working in the laboratories
Basic Requirements:
• Degree in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences with experience in drug discovery, or a higher degree with research experience relevant to drug metabolism or mass spectrometry science
• PhD with 0+ years, MS with 0 – 5+ years, or BS with 5 – 10+ years of relevant experience
• Title and salary will be commensurate with experience
The ideal candidate will draw from any the following key skillsets:
• Familiarity with in vitro systems (hepatocytes, microsomes, S9 fraction, recombinant enzymes)
• Hands-on experience in operation, maintenance, and troubleshooting of state-of-the-art high resolution orbitrap and inductively coupled plasma mass spectrometers
• Experience with HPLC/UPLC, ion pairing and size exclusion chromatography
• Prior experience with either oligonucleotide and/or intact protein analysis is desired but not required
• Excellent oral and written communication skills
• Careful attention to detail, exceptional organizational skills and ability to multitask
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.
How to apply:
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Job page link:
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R2622188 Principal Scientist, DMPK Sanofi (Filled May, 2022)
Company: Sanofi
Location: Waltham, MA (Jan-June) then Cambridge, MA, USA (from July onward)
Job Description: Principal Scientist
Company Overview
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into
breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and
inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000
colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we
deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
Position Overview
Sanofi is seeking an energetic and self-motivated scientist to join the Drug Metabolism and
Pharmacokinetics (DMPK) research platform of the North American Hub. As a member of the DMPK
department you will join a team of DMPK scientists to support the discovery projects in the therapeutic
areas of Rare and Neuro Diseases, Rare Blood Disorders, Immunology and Inflammation, and Immunooncology.
Key Responsibilities:
Evaluate and monitor in vitro ADME outsourcing activities at CROs, including but not limited to metabolism,
protein binding, tissue partitioning, and drug-drug interaction. Perform complex data analysis for
interpreting ADME properties for establishing in vitro-in vivo correlations and translation to human. Manage
CROs for in vitro assays to characterize enzyme kinetics, reaction phenotyping, and drug-drug interaction
potential for potential small molecule clinical candidates. Develop and execute novel cell-based assays to
investigate non-routine issues when applicable. Develop tools and design in vivo experiments to enable
the investigation of ADME related project issues. Promote innovative approaches for the advancement of
drug candidates across various modalities including small molecules, RNA, and biotherapeutics.
Approaches to innovative computational ADME is a plus.
The role also includes the review of reports generated from CROs and the preparation of study reports for
regulatory submissions. Highly qualified candidates may also be provided the opportunity to represent
DMPK on project teams.
Basic Requirements:
- A Ph.D. in Drug Metabolism or Pharmacokinetics with 5+ years of relevant post-graduate
experience. - Ability to independently conduct in vitro ADME studies, propose and/or generate new tools to
address metabolism and other ADME issues. - Extensive knowledge of drug metabolism and pharmacokinetics in a research setting.
- Ability to keep current with literature and report scientific data in a public forum.
- Ability to initiate and implement new research ideas. Summarize research results into
scientific presentation and manuscript. - Demonstrate strong written and verbal communication skills and have a solid scientific
publication record. - Able to work in a collaborative environment and contribute to high scientific rigor.
- Demonstrate ability to work in a matrix environment and in a global environment.
Apply by visiting:
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Senior / Principal Scientist, DMPK Relay Therapeutics
Company: Relay Therapeutics
Location: Cambridge, MA, USA
Job Description: Senior / Principal Scientist, DMPK
The Opportunity:
Are you a versatile and self-motivated scientist who looks to advance drug discovery programs towards the clinic? Then we’re looking for you! You will have an opportunity to join a growing DMPK team and be a functional lead on assigned project teams developing small molecule modulators of clinically meaningful and validated targets in cancer and genetic diseases. We are looking for a consummate teammate who seeks a scientifically rigorous and collaborative environment with huge potential for growth and learning.
Your Role:
- You will be the functional area representative for DMPK on multidisciplinary project teams.
- You will design and execute a broad array of in silico, in vitro and in vivo DMPK studies to drive program progression and decision making.
- You will collaborate internally across all disciplines as well as manage experimental work at CRO partners.
- You’ll play a part in enhancing DMPK approaches to supporting drug discovery.
Your Background:
- You have a PhD with exposure to DMPK-related research or relevant postdoctoral experience.
- You are scientifically curious and rigorous, and are driven to learn.
- You’re comfortable navigating complexity and ambiguity in an environment that is constantly changing.
- You’re an articulate, open communicator (both oral and written) with the ability to analyze, interpret and present data in a clear manner.
About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
Company policy requires that all employees be fully vaccinated against COVID-19, and all new hires must be fully vaccinated (as defined by the CDC) by the time they start employment. By applying to this position, you are confirming that, if hired, you can satisfy this express condition of employment. The Company will make reasonable accommodations under applicable law for qualified individuals to enable them to perform the essential functions of the job, unless doing so would create an undue hardship for the Company.
Apply by visiting:
https://boards.greenhouse.io/relaytherapeutics/jobs/4250196004
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ADME Senior Scientist, EUROFINS VILLAPHARMA
Company: EUROFINS VILLAPHARMA
Location: Murcia, Spain
Job Description: ADME Senior Scientist
EUROFINS VILLAPHARMA is seeking an ADME Senior Scientist based in Murcia (Spain) with a strong experience in and understanding of absorption, distribution, metabolism and excretion (ADME) of drugs and related toxicology.
EUROFINS VILLAPHARMA is expanding its footprint with the opening of a new research Centre in early 2021 to serve the growing market of outsourced drug discovery with its high quality chemistry capabilities. That person will play a pivotal role in maintaining a productive a collaborative working environment.
The position comprises mainly of designing and directing the in vitro metabolism assay panel we perform for our customers, instructing and supporting laboratory technicians and scientist in their experiments, processing and interpreting the experimental data into results and reports, and communicating with our customers.
Responsibilities:
- Responsible for performing and reporting in vitro metabolism ADME studies for discovery stage compounds.
- Actively participate in experimental design, perform experiments as well as critically analyse, interpret and report the data to design next steps.
- Ability to perform high-impact as well as high throughput studies to completion in a fast paced environment, while managing multiple projects to meet the timelines.
- Provides scientific knowledge and responsible in establishing new ADME assays as well as contribute to the continuous improvement of the current ADME assays
- Perform Quality Review of peer data and assist in consolidating assay control and validation criteria.
- Ensure work is conducted within set timeframes and to the highest scientific and regulatory standards.
Qualifications
We are looking for a professional with these required skills:
- BS/MS in a scientific relevant field with at least 2 years of related experience in contract research organizations, pharmaceutical industries or academia. (Ph.D. preferred).
- Industry/academic experience in DM/PK with solid understanding of pharmacology and ADME concepts.
- Knowledge of bioanalytical sciences including LC-MS/MS, GC-MS, and physical organic chemistry.
- Experienced in cell based or biochemical assays.
- Ability to work in a team environment, remaining attentive to ideas, recognizing responsibilities, and actively participating with others to accomplish assignments and achieve desired goals.
- Excellent oral and written communication skills.
- Strong attention to detail.
- Ability to manage time and works independently.
- Experience working and influencing in a cross functional , matrix environment
- Proven ability to manage a broad variety of projects and priorities.
Preferred Experience:
- Extensive knowledge in synthetic organic chemistry, both theoretical and practical.
- Experience in lead optimization, SAR analysis and drug design.
- Experience in drug discovery/development.
Additional Information
Offered:
– Immediate incorporation into a multinational group with strong growth.
– Good work environment, career plan, etc …
– Salary: Negotiable individually according to value and experience provided.
Apply by visiting linkedin site or contact:
Ginés Nieto: GinesNietoGarcia@eurofins.com
Telephone: +34 968 197 524
https://www.linkedin.com/jobs/view/2879533205/
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