Sr. Manager/Manager, Manufacturing
$140,000–$180,000 year
On-site · Alameda, California, United States
Job Summary
Lead and manage daily cGMP manufacturing operations across cell and gene therapy programs; build and retain a high-performing manufacturing team; ensure quality, regulatory compliance, and patient safety; collaborate with MSAT on Engineering Runs and Technology Transfer; work with QA to close deviations, CAPAs, and change controls; approve GMP-controlled documents; develop a comprehensive training program for cGMP operations; manage scheduling and on-the-floor support; drive continuous improvement, KPI tracking, and budgeting; support regulatory inspection readiness and cross-functional partnerships across Quality, Supply Chain, MSAT, EHS, Facilities and Engineering; mentor and develop talent from entry-level to senior supervisors.
Required Qualifications
- Bachelor’s degree in a relevant science or engineering discipline
- Minimum of 6 years of experience in pharmaceutical/biotechnology or similarly regulated industry with at least 5 years direct hands-on experience in cGMP biologics or cell and gene therapy manufacturing
- Minimum of 3 years in a supervisory or management role with direct people leadership responsibility
- Experience in cell and gene therapy manufacturing (autologous or allogeneic cell therapy, lentiviral or AAV vector production) strongly preferred; CDMO experience a significant plus
- Strong technical writing capability with experience authoring, reviewing, approving, and training staff on SOPs, batch records, change controls, deviations, and CAPAs
- Thorough knowledge of cGMP regulations and regulatory guidelines including 21 CFR Parts 210/211/600/610 and EU GMP, with a demonstrated track record of maintaining compliance in a regulated manufacturing environment
- Proven leadership ability to make sound decisions under pressure, manage competing priorities, and drive accountability across a manufacturing team in a dynamic, multi-program environment
- Strong interpersonal and communication skills with ability to build effective relationships across functions
- Proficient in MS Office; familiarity with EBR, MES, and QMS platforms preferred
- Compensation ranges listed: Manager 140-160K; Sr. Manager 160-180K
- Ability to lead and develop manufacturing talent across all levels; oversee capacity planning and regulatory inspection readiness
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