Bristol Myers Squibb
Principal Scientist, Bioanalytical Lead
Bristol Myers Squibb, Princeton, New Jersey, us, 08543
Bristol Myers Squibb Principal Scientist, Bioanalytical Lead Princeton, New Jersey Apply Now
Challenging. 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 close 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, oversees assay development/validation/performance monitoring at CROs, ensures on-time, high quality delivery of data and reports in support of drug development.Provide leadership in authoring and reviewing of regulatory filing documents (IND, NDA/BLA, IB, etc) and interacts with Health authority on BA related inquiries.Represent regulated bioanalysis on cross-functional teams and contribute to the improvements to 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, biomarker, 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 travels to CROs for monitoring visits.Basic QualificationsBachelor's Degree with 8+ years of academic and/or industry experience, orMaster's Degree with 6+ years of academic and/or industry experience, orPh.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 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.
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Challenging. 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 close 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, oversees assay development/validation/performance monitoring at CROs, ensures on-time, high quality delivery of data and reports in support of drug development.Provide leadership in authoring and reviewing of regulatory filing documents (IND, NDA/BLA, IB, etc) and interacts with Health authority on BA related inquiries.Represent regulated bioanalysis on cross-functional teams and contribute to the improvements to 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, biomarker, 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 travels to CROs for monitoring visits.Basic QualificationsBachelor's Degree with 8+ years of academic and/or industry experience, orMaster's Degree with 6+ years of academic and/or industry experience, orPh.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 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.
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