Senior Manager, Cell Therapy Manufacturing (Devens, MA)
Shifts Available: TBD
Responsibilities:
- Serve as manufacturing functional area owner and manage commercial and clinical manufacturing teams and areas.
- Hire, mentor, and develop staff; conduct performance reviews and identify growth opportunities.
- Ensure training for CAR-T GMP manufacturing in a multi-product commercial facility.
- Build cross-functional relationships with Quality, Supply Chain, MS&T, EHS, and F&E.
- Ensure safety culture and compliance with company procedures/policies and cGMP requirements.
- Plan for and execute commercial and clinical operations for licensed CAR-T product at the Devens CTF Manufacturing Plant, including:
- Establish department goals, track/report KPIs, drive continuous improvement/lean initiatives.
- Author/review/approve SOPs, batch records, material specs, training materials, and validation protocols/reports.
- Develop and communicate project goals, strategy, and timelines.
- Implement/operate technically sound manufacturing systems compliant with cGMP.
- Establish/maintain schedules for people, facility, equipment, materials, and documents.
- Identify/mitigate manufacturing risks affecting delivery of safe/effective therapies.
- Lead inspection readiness/right-first-time manufacturing.
- Set team/organizational and shift structures and career ladders.
Minimum Requirements:
- Bachelorβs degree in relevant science/engineering (or equivalent experience).
- Knowledge of Lean Manufacturing principles.
- Ability to work in cleanroom PPE; work near strong magnets.
- 8+ years in pharmaceutical or similarly regulated industry.
- 6+ years supervising staff in a management role.
Compensation/Benefits (as listed):
- US $131,750β$159,650 (Devens, MA). Additional incentive cash/stock may be available.
- Health coverage; wellbeing support; 401(k) and protection benefits.
- Paid time off (flexible time off/annual vacation and holidays per eligibility).