Job Description

Scientific Director, Regulated Bioanalysis and Mass Spectrometry Scientific Director, Regulated Bioanalysis and Mass Spectrometry Apply locations Princeton - NJ - US time type Full time posted on Posted 2 Days Ago job requisition id R1590026 Working with Us 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 Summary The Regulated Bioanalysis & Mass Spectrometry (RBMS) function within Precision Medicine, Bioanalytical and Translational Sciences (PMBATS) department is a centralized function for testing biological samples for Pharmacokinetics (PK), biomarkers (PD), and Immunogenicity assessments during the development stage. This is an On Site Position located in our Princeton, NJ location. The responsibilities of the groups include providing bioanalytical leadership for PK and PD on BMS drug development teams via scientific/technical expertise and strategic input; overseeing and/or performing assay development/validation, and sample analysis; supporting 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 will be responsible for providing strategic bioanalytical leadership for PK and PD of BMS drug candidates during the development stage. Reporting to the Executive Director for RBMS, the candidate will lead a hybrid team with outsourcing scientists for PK and on-site PD biomarker LC/MS scientists. Key responsibilities include managing group resources, interacting with cross-functional teams in BMS, overseeing method development, validation, and sample analysis projects, as well as handling regulatory interactions for PK and PD related to BMS development candidates. Key Responsibilities Formulate and implement an LC/MS-based biomarker strategy aligned with translational objectives during the development stage. Lead assay development and sample analysis activities within the in-house biomarker LC/MS laboratory. Collaborate with cross-functional teams to provide LC/MS expertise, ensuring the selection of appropriate technologies to achieve pharmacodynamic (PD) objectives. Develop and implement bioanalytical PK strategies for BMS development compounds, from GLP studies through life cycle management. Provide leadership in authoring and reviewing regulatory filing documents, including IND, NDA/BLA, IB, and others. Recruit, mentor, guide, and retain scientific staff within the functional area. Evaluate the performance of subordinate staff and actively contribute to their technical, personal, and career development. Represent the bioanalytical function on Developmental Project Teams and contribute to the advancement of projects. Assist department line management in establishing long-term goals, forecasting budgets, formulating action plans to achieve goals, and assessing success. Enhance the scientific credibility of BMS through contributions to scientific literature (publications and presentations), participation in extramural activities, and interactions with academic and health authorities. May require travels to CROs for monitoring visits. Qualifications & Experience Ph.D. or equivalent advanced degree in the Life Sciences with 13+ years of academic and/or industry experience. Or Master’s Degree with 16+ years of academic and/or industry experience. Or Bachelor’s Degree with 18+ years of academic and/or industry experience. A PhD degree in a related field is preferred. Demonstrated scientific expertise in proteomics, target engagement, post-translational modifications (PTM), and other translational objectives. Strong background in high-resolution mass spectrometry (HRMS) and LC/MS-MS based bioanalytical techniques. Working understanding of biomarker support regulatory guidelines and frameworks during the development stage. In-depth knowledge of the principles of regulated bioanalysis and a thorough understanding of GxP regulations. Preferably, candidates should have management experience in regulated bioanalysis, including people management, project leadership, and cross-functional leadership within a bioanalytical organization (CRO or pharmaceutical company). Proven track record of accomplishments in team management and cross-functional leadership, with prior management experience at a CRO or pharmaceutical company. Well-versed in current bioanalytical guidance for small molecules, biomarkers, and biotherapeutics, as well as regulatory expectations for validations and study conduct. #J-18808-Ljbffr Bristol-Myers Squibb

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