Bristol Myers Squibb · 1 day ago
ASSOCIATE DIRECTOR, GPS STABILITY
New Brunswick, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$169K/yr - $205K/yr
10+ years expBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. The Associate Director Stability is responsible for overseeing product stability programs for large molecules and leading a high-performance technical team to ensure successful commercialization and compliance with health authority regulations.
BiotechnologyMedical DeviceHealthcarePharmaceuticalHealth CareMedicalPrecision Medicine
Responsibilities
The Associate Director Stability is accountable for the stability commercial program for large molecules Drug Substances and Drug Products
Accountable for new products commercialization and providing support to the sites or external manufacturing for new products commercialization
Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
Accountable for the handling of annual commercial stability program for assigned products in coordination with sample management group
Provides technical expertise to the stability team
Provides support for authoring stability sections of filling dossiers for post-approval filings, and stability related responses to health authority inquiries
Approves the stability sections of filling dossiers, annual reports, product renewals, Annual Product Stability Reviews
Provide support for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues or capacity issues
Accountable for stability procedures and ensures consistency with site department and BMS groups procedures
Leads OpEx initiatives to streamline and standardize management of stability programs
Supports health authorities' inspection internal and external
Leads the team and focus on the pipeline complexities to achieve milestones and objectives, while providing technical oversight, mentorship, and coaching
Leads with a global mind-set to direct and influence multiple remote teams
Drives sense of team responsibility for group's success, promoting a high commitment to business goals and objectives
Accountable for stability resources definition and budget
Fosters a culture focused on demonstrating high capacity for executing with company values and behaviors
Provides continuing development opportunities, including ongoing performance assessments
Qualification
Required
10 years of relevant work experience required, preferably in a pharmaceutical environment
2 years' experience as team manager
Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents
A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility
Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices
Expert Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods
Significant Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
Excellent skills to drive development of technical or scientific initiatives for solving complex problems/issues, recommending and drive science-based decisions/ implementation of solutions
Significant experience on health authorities' inspections in front room
Excellent written and verbal communication skills
Leadership experience Team, conflict management, coaching others, talent selection, developing others, decision-making, building relationships, innovation management, and resource allocation
Advanced knowledge of Microsoft office applications, LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP)
Benefits
Health Coverage Medical, pharmacy, dental, and vision care.
Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.33BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.75B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-02-11
2026-02-11
Company data provided by crunchbase