Scientific Director, Bioanalysis

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. Read more:careers.bms.com/working-with-us .

Position Summary

The Bioanalytical (BA) function within Translational Medicine/Clinical Pharmacology is a centralized function for testing biological samples for Pharmacokinetics (PK), biomarkers, and Immunogenicity assessments during the development stage. 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 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 oversight for LC-MS project management and leadership. Reporting to the Executive Director for Regulated Bioanalysis, the candidate will lead a team that provides bioanalytical support for BMS development projects. Key responsibilities include managing group resources, overseeing bioanalytical method development, validation, and sample analysis projects, as well as handling regulatory interactions related to BMS development candidates.

This is an On Site Position located in our Princeton, NJ location.

Key Responsibilities

Develop and implement bioanalytical 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.
Oversee internal laboratory groups and bioanalytical leads for outsourced studies, focusing on method development, validation, and sample analysis tasks.
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

Bachelor's Degree18+ years of academic and / or industry experience

Or
Master's Degree16+ years of academic and / or industry experience

Or
Ph.D. or equivalent advanced degree in the Life Sciences13+ of academic and / or industry experience

A PhD degree in a related field is preferred.
Demonstrated management experience in regulated bioanalysis, including people management, project leadership, and cross-functional leadership within a bioanalytical organization (CRO or pharmaceutical company) is required.
Strong expertise in LC/MS-based bioanalysis techniques is essential.
In-depth knowledge of the principles of regulated bioanalysis and a thorough understanding of GxP regulations.
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.

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto 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:https://careers.bms.com/california-residents/

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