Senior Bioanalytical Lead
4 weeks ago
Transforming Patients' Lives through Science
Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Senior Bioanalytical Lead to join our team.
The successful candidate will provide bioanalytical leadership for BMS development programs using LC-MS technology. This will involve working 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 Responsibilities:
- Provide 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, ensure 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 interact 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.
Requirements:
- Bachelor's Degree or higher in a relevant field.
- 8+ years of academic and/or industry experience.
- PhD or equivalent advanced degree in the Life Sciences preferred.
Bristol Myers Squibb is an Equal Opportunity Employer
We are committed to creating a diverse and inclusive work environment that reflects the communities we serve. We welcome applications from qualified candidates who share our values and are passionate about making a difference in the lives of patients.
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