NIGHT SHIFT: Senior Manager, Cell Therapy Manufacturing in Devens, MA
About The Position
The Senior Manager, Cell Therapy Manufacturing supports clinical and commercial operations at the Devens Cell Therapy Facility. The role leads the people and manufacturing areas responsible for producing clinical and commercial products, overseeing shifts that cover 24/7 cell therapy unit operations—including media preparation, cell selection, cell processing, and product fill—in accordance with current Good Manufacturing Practices (cGMP). The Senior Manager manages manufacturing teams and areas, develops staff, and partners with cross-functional groups. The role plans and executes operations for licensed CAR-T products, establishes department goals and tracks KPIs, drives continuous improvement, and ensures that manufacturing systems, schedules, staffing, facilities, equipment, materials, and documentation support facility capacity and compliant product delivery. The position also leads risk mitigation, inspection readiness, and right-first-time manufacturing efforts, while establishing team and shift structures and career ladders.
Requirements
- Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
- Knowledge of Lean Manufacturing principles.
- At least 8 years of relevant work experience in the pharmaceutical industry or a similarly regulated industry.
- At least 6 years supervising staff in a management role.
- Ability to wear cleanroom garments and personal protective equipment in designated areas, covering the head, parts of the face, core body, and legs or feet.
- Ability to work in the vicinity of strong magnets.
Responsibilities
- Serve as manufacturing functional area owner and manage commercial and clinical manufacturing teams and areas.
- Hire, mentor, and develop employees; conduct performance reviews and identify career-growth opportunities for supervisors and associates.
- Promote teamwork and communication across the organization.
- Ensure employees maintain the training required for CAR-T GMP manufacturing in a multi-product commercial facility.
- Build effective cross-functional relationships with Quality, Supply Chain, MS&T, EHS, and F&E.
- Promote workplace and patient safety through compliance with company procedures, policies, and cGMP requirements, and model these behaviors.
- Plan and execute commercial and clinical operations for a licensed CAR-T product in the Devens CTF Manufacturing Plant.
- Establish department goals, track and report KPIs, and drive continuous improvement through innovation and lean manufacturing initiatives.
- Author, review, and approve documents, including standard operating procedures, batch records, material specifications, training materials, and validation protocols and reports.
- Develop and communicate project goals, strategy, and timelines with manufacturing management.
- Implement and operate technically sound manufacturing systems that support effective, efficient, cGMP-compliant operations.
- Establish and maintain schedules for people, facilities, equipment, materials, and documents to support expected facility capacity across multiple CAR-T products.
- Identify and mitigate manufacturing risks that could negatively affect delivery of safe and effective therapies to patients.
- Lead inspection-readiness efforts and initiatives for right-first-time manufacturing.
- Establish team policies, organizational and shift structures, and career ladders for Associates, Team Leaders, Supervisors, and Managers.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
- Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
- For eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval.
- 11 paid company holidays each year.
- Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
- Potential eligibility for additional discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
