Bristol-Myers Squibb
Principal Scientist, Bioanalytical Lead
Bristol-Myers Squibb, Princeton, New Jersey, us, 08543
Principal Scientist, Bioanalytical Lead
Apply to locations: Princeton - NJ - US, Summit West - NJWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.Position SummaryThe Bioanalytical (BA) function within CPPB is a centralized function for testing biological samples for Pharmacokinetics (PK), ADME biomarkers, and Immunogenicity assessments. The responsibilities of the groups include providing bioanalytical leadership on BMS drug development teams via scientific/technical expertise and strategic input; overseeing and/or performing assay development/validation, and sample analysis; supporting discovery studies for biotherapeutics and regulated and non-regulated bioanalysis for toxicology and clinical studies; and preparing appropriate documentation and/or interacting with health authorities on the BA portion of regulatory filings. The BA groups utilize both internal resources and external strategic partners to ensure on-time delivery of BA data to enable key decisions for the organization.The candidate for this position has the responsibilities of providing bioanalytical leadership for BMS development programs using LC-MS technology. The candidate for this position works closely with internal groups and CROs to provide bioanalytical method development/validation/sample analysis expertise, as well as regulatory interactions on BMS development candidates.Key ResponsibilitiesProvide bioanalytical strategies related to BMS development compounds from GLP studies to life cycle management.Provide leadership for bioanalytical issues for BMS development candidates on project teams, oversee assay development/validation/performance monitoring at CROs, and ensure on-time, high-quality delivery of data and reports in support of drug development.Provide leadership in authoring and reviewing regulatory filing documents (IND, NDA/BLA, IB, etc.) and interact with health authorities on BA related inquiries.Represent regulated bioanalysis on cross-functional teams and contribute to improvements in processes.Act as LC-MS Technology lead on cross-functional teams for non-routine LC-MS BA analysis responsibilities such as protein binding, AMS, LC-MS technology lead on biologics, biomarkers, etc.Enhance the scientific credibility of BMS through contributions to the scientific literature (publications/presentations), through extramural activities and scientifically related interactions with academic and health authorities.May require travel to CROs for monitoring visits.Basic QualificationsBachelor’s Degree with 8+ years of academic and/or industry experience.Or Master’s Degree with 6+ years of academic and/or industry experience.Or Ph.D. or equivalent advanced degree in the Life Sciences with 4+ years of academic and/or industry experience.Preferred QualificationsA candidate with a PhD degree in a related field is preferred.A demonstrated background in regulated LC-MS bioanalysis project management in a regulated organization (a CRO or a pharmaceutical company) is required.The candidate must be well versed with sample preparation, chromatographic separation, and mass spectrometric technology utilized in regulated bioanalysis.The candidate should have a strong background in the principles utilized in regulated bioanalysis, including a thorough understanding of GxP regulations and ICH M10.A demonstrated record of accomplishments in cross-functional leadership, scientific presentations, time management, and the ability to work in a methodical and organized fashion.Ability to multi-task and work in a collaborative team environment.Ability to communicate effectively in a team-based environment.#LI - HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.
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Apply to locations: Princeton - NJ - US, Summit West - NJWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.Position SummaryThe Bioanalytical (BA) function within CPPB is a centralized function for testing biological samples for Pharmacokinetics (PK), ADME biomarkers, and Immunogenicity assessments. The responsibilities of the groups include providing bioanalytical leadership on BMS drug development teams via scientific/technical expertise and strategic input; overseeing and/or performing assay development/validation, and sample analysis; supporting discovery studies for biotherapeutics and regulated and non-regulated bioanalysis for toxicology and clinical studies; and preparing appropriate documentation and/or interacting with health authorities on the BA portion of regulatory filings. The BA groups utilize both internal resources and external strategic partners to ensure on-time delivery of BA data to enable key decisions for the organization.The candidate for this position has the responsibilities of providing bioanalytical leadership for BMS development programs using LC-MS technology. The candidate for this position works closely with internal groups and CROs to provide bioanalytical method development/validation/sample analysis expertise, as well as regulatory interactions on BMS development candidates.Key ResponsibilitiesProvide bioanalytical strategies related to BMS development compounds from GLP studies to life cycle management.Provide leadership for bioanalytical issues for BMS development candidates on project teams, oversee assay development/validation/performance monitoring at CROs, and ensure on-time, high-quality delivery of data and reports in support of drug development.Provide leadership in authoring and reviewing regulatory filing documents (IND, NDA/BLA, IB, etc.) and interact with health authorities on BA related inquiries.Represent regulated bioanalysis on cross-functional teams and contribute to improvements in processes.Act as LC-MS Technology lead on cross-functional teams for non-routine LC-MS BA analysis responsibilities such as protein binding, AMS, LC-MS technology lead on biologics, biomarkers, etc.Enhance the scientific credibility of BMS through contributions to the scientific literature (publications/presentations), through extramural activities and scientifically related interactions with academic and health authorities.May require travel to CROs for monitoring visits.Basic QualificationsBachelor’s Degree with 8+ years of academic and/or industry experience.Or Master’s Degree with 6+ years of academic and/or industry experience.Or Ph.D. or equivalent advanced degree in the Life Sciences with 4+ years of academic and/or industry experience.Preferred QualificationsA candidate with a PhD degree in a related field is preferred.A demonstrated background in regulated LC-MS bioanalysis project management in a regulated organization (a CRO or a pharmaceutical company) is required.The candidate must be well versed with sample preparation, chromatographic separation, and mass spectrometric technology utilized in regulated bioanalysis.The candidate should have a strong background in the principles utilized in regulated bioanalysis, including a thorough understanding of GxP regulations and ICH M10.A demonstrated record of accomplishments in cross-functional leadership, scientific presentations, time management, and the ability to work in a methodical and organized fashion.Ability to multi-task and work in a collaborative team environment.Ability to communicate effectively in a team-based environment.#LI - HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based, and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.
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