Principal Scientist, Bioanalytical Lead

Working with Us

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Position Summary

The 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 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 none-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 Qualifications

• Bachelor's Degree

• 8+ years of academic and / or industry experience

Or

• Master's Degree

• 6+ years of academic and / or industry experience

Or

• Ph.D. or equivalent advanced degree in the Life Sciences

• 4+ years of academic and / or industry experience

Preferred Qualifications

• A 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.

#LI - Hybrid

If 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 Careers

With 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 Protocol

BMS 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:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ~~~ . Visit ~~~/ (~~~) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ~~~/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1585915

Updated: 2024-09-30 06:06:21.732 UTC

Location: Princeton-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.