Lead Therapist overseeing therapy team and providing evidence - based treatment for chemical dependency. Focus on individual patient care and program development in a clinical setting.
BS
Hybrid Associate Director, Breyanzi Product Champion, Cell Therapy Technical Operations
Posted last month
About the role
- Associate Director leading technical agenda for Breyanzi commercial cell therapy products. Driving strategic technology roadmap for Breyanzi manufacturing and lifecycle management.
Responsibilities
- Own the Drug Product (DP) Technical Roadmap for Breyanzi, ensuring alignment with franchise strategy, commercial objectives, and technical innovation.
- Serve as technical lead for post-market process changes, technology transfers, and process optimization initiatives across internal and external manufacturing sites.
- Coordinate technology transfer (TT), validation, and regulatory submission strategies in collaboration with Lifecycle Management (LCM) and cross-functional partners.
- Act as technical subject matter expert for Breyanzi, providing expertise and leadership on product and process matters.
- Lead weekly strategy and execution meetings by setting agendas, driving discussions, coordinating operational progress and troubleshooting, and ensuring follow-up on action items across cross-functional teams.
- Attend and actively participate in meetings with TPT (and Go Team as needed) to ensure effective communication and alignment on technical and strategic objectives.
- Ensure representation from all manufacturing sites, External Manufacturing (ExM), and laboratory teams in relevant meetings and decision-making processes.
- Collaborate with clinical and manufacturing sites to develop and implement innovative technologies that enhance product quality, robustness, and cost efficiency.
- Provide technical justification and direction for change controls, investigations, and regulatory submissions.
- Author and review technical documentation for regulatory filings, product quality reviews, and governance presentations.
- Manage global change controls, CAPAs, and proactive compliance initiatives.
- Represent Breyanzi product teams in regulatory interactions, inspections, and internal/external forums, including committees and industry groups on development, technology transfer, manufacturing, specifications, process validations, and launch.
- Identify product cost drivers and realizes opportunities for cost reduction early in product/process development or as part of post-filing improvements.
- Assist the manufacturing sites globally to resolve significant quality events that require in-depth technical expertise.
- Mentor junior team members and foster a culture of accountability, inclusion, and innovation.
- Promote diversity, equity, and inclusion in team dynamics and project execution.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Biology, Chemistry, Biochemical/Chemical Engineering, or related field.
- Advanced degree (M.S./Ph.D.) preferred; equivalent experience considered.
- Minimum of 12+ years of relevant experience in cell therapy, biologics, or pharmaceutical manufacturing.
- Proven experience leading technical projects in a matrixed environment.
- Strong knowledge of cGMP operations, process validation, regulatory compliance, and change management.
- Experience with Cell Therapy Drug Product Manufacturing and sterile drug product operations.
- Excellent communication, strategic thinking, and problem-solving skills.
- Experience with project management tools and Lean Six Sigma methodologies is a plus.
- Ability to travel up to 20%.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
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