Bristol Myers Squibb · 1 day ago
Associate Director, Product Technical Steward, Cell Therapy Technical Operations
Madison, NJ
Full-time
Onsite
Lead/Staff, Director/Executive
$178K/yr - $216K/yr
12+ years expBristol Myers Squibb is a biopharmaceutical company that transforms the lives of patients through innovative therapies. The Associate Director, Product Technical Steward, Cell Therapy Technical Operations will lead cross-functional teams in managing the Drug Product technical project portfolio and ensure process readiness for commercialization.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Develop strategy for the product franchise by representing Drug Product on product strategy teams and leading a cross-functional team that manages the Drug Product technical project portfolio
Be the primary owner of the Drug Product process, and leads or participates in process validation, regulatory filings, regulatory inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement, and other initiatives
Interact regularly with product development to ensure process readiness for commercialization, assess resources required, communicating progress and risks, and presenting timelines and strategies for endorsement
Represent the Drug Product manufacturing process in regulatory interactions such as inspections and other meetings
Work with Drug Product manufacturing site teams to troubleshoot manufacturing issues and develop process improvements. Collaborate closely with analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sciences to drive the franchise strategy
The position requires resolution of complex problems through strong leadership of cross-functional teams to meet product quality, schedule, and cost objectives
Strategic Planning Defines strategy for the product franchise by representing Drug Product on product strategy teams and leads a cross-functional technical team that creates and governs the Drug Product technical project portfolio for the designated product
Technical Oversight Collaborate with process development and analytical development to ensure early pipeline assets have a robust process
Key Deliverables Primary owner of the Drug Product process for the designated product. Technical content and strategy across tech transfers, process validation, technical reports, data analysis, process monitoring, change control and implementation, product comparability and escalated support of technical/scientific process and analytical issues
Regulatory & Documentation Provide technical content for documents such as PPQ protocol or comparability assessments, author content for regulatory submissions and annual product quality review, present technical strategies during major health authority interactions and inspections
Cross Functional Leadership Collaborates closely with analytical, quality, regulatory, operations, development, supply chain, strategy, third party manufacturing and manufacturing sciences roles to drive the brand strategy and prevent supply disruptions. Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites. Oversees implementation of lifecycle management projects and responsible for gaining consensus on change implementation strategies that ensure robust Drug Product supply
Qualification
Required
B.S/MS/PhD in Chemical Engineering or Biology, Chemistry, Biochemical (Life Science) with 12+ years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of technical leadership responsibilities and scope
Previous experience should be a combination of technical operation functions such as manufacturing, quality, MS&T (Technical operations) or Technical Development
Should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above
Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for Drug Product manufacturing and processing equipment, manufacturing support and technology transfer
Ability to define the right processes for the team's maturity level, balancing agility and discipline
Ability to assess risk and develop contingency plans for process risks
Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities
Detail oriented with excellent verbal and written communication skills
Strong interpersonal and leadership skills to work with teams in different functions and organizations
Experience leading regulatory inspections regarding tech transfer, validation and extensive knowledge of regulations, current industry practices
Should have demonstrated the skill to lead large, complex technical organizations with a global scope and build processes, and technology in a growing organization
Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required
Preferred
2-3 years of experience in cell therapy process development and or manufacturing
Combination of experience in process development, MS&T and quality, experience with manufacturing automation systems/platform
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
Eligibility Disclosure The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
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
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
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
MedCity News
2026-01-06
Dallas Morning News
2026-01-05
2025-12-30
Company data provided by crunchbase