Senior Bioanalytical Scientist
6 days ago
Bristol Myers Squibb is a global biopharmaceutical company that is committed to transforming patients' lives through science. We are seeking a highly skilled and experienced Bioanalytical Scientist to join our team in a key role that will contribute to the development of innovative medicines.
About the Role
The successful candidate will be responsible for providing 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, 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.
Requirements
The ideal candidate will have a strong background in regulated LC-MS bioanalysis project management in a regulated organization (a CRO or a pharmaceutical company). They should be well-versed with sample preparation, chromatographic separation, and mass spectrometric technology utilized in regulated bioanalysis. A demonstrated record of accomplishments in cross-functional leadership, scientific presentations, time management, and the ability to work in a methodical and organized fashion is also required.
What We Offer
Bristol Myers Squibb offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment that values and respects the contributions of all employees.
How to Apply
If you are a motivated and experienced Bioanalytical Scientist looking for a new challenge, please submit your application, including your resume and a cover letter, to our website. We look forward to hearing from you.
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