Associate Director, Product Technical Steward Devens, MA
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Job Location:
Devens, MA - USA
Monthly Salary:
$ 178420 - 216197
Posted on:
11-11-2025
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. 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.
The Associate Director Product Technical Steward Cell Therapy Technical Operations (CTTO) is highly cross-functional and challenging involving leadership across all sites of Drug Product manufacture for the designated product.
In this role the Technical Steward will:
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.
Key Responsibilities:
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.
Additional Qualifications/Responsibilities
Qualifications & Experience:
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 teams maturity level balancing agility and discipline.
Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred.
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
Additional preferred qualifications:
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.
This position will require up to 20% travel.
Compensation Overview:
Devens - MA - US: $178420 - $216197
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Required Experience:
Director
Key Skills
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
