Manager, Production Operations & GMP
About The Position
Maravai LifeSciences is seeking a #MiracleMaker to join our Process Development team as a Manager, Production Operations & GMP. As a Manager, Production Operations & GMP you will lead a team of technical subject matter experts and GMP support staff to ensure efficient, compliant, and innovative manufacturing operations. This role provides technical leadership for production processes, supports technology transfers, and drives continuous improvement initiatives. Responsibilities include coaching and mentoring manufacturing teams, sustaining process knowledge, optimizing workflows, and overseeing cleanroom operations and GMP compliance. Acting as a technical liaison, the Manager will collaborate cross-functionally with Manufacturing, Quality, R&D, Supply Chain, and Commercial teams to support new product introductions, customer projects, and investigations. This position requires strong expertise in biologics manufacturing, cleanroom operations, and GMP standards, with the ability to operate semi-independently and deliver solutions in a fast-paced CDMO environment.
Requirements
- Ph.D. with 2+ years, M.S. with 4+ years, or B.S. with 6+ years of experience in a scientific field (Biology, Chemistry, Biochemistry, or Engineering).
- Minimum 4–6 years of relevant experience in biotech or pharmaceutical development, including at least 2 years in a supervisory or leadership role.
- Strong knowledge of cGMPs, 21 CFR 210/211, 21 CFR 820, ICH Q7, ISO 9001, and/or ISO 13485 requirements.
- Experience leading technology transfers, process qualification, and validation.
- Familiarity with biologics manufacturing, CDMO operations, and ISO 14644 cleanroom classifications.
- Ability to draft and review GMP documentation (SOPs, batch records, deviations, CAPAs, change controls, validations).
- Experience with electronic quality systems and ERP platforms (e.g., NetSuite).
- Excellent written and verbal communication skills with experience supporting strategy development and implementation.
- Proven ability to manage and mentor teams, work cross-functionally, and drive strategic initiatives.
- Strong collaboration skills and ability to influence across departments.
- Ability to implement processes that deliver measurable results and adapt best practices in novel technology environments.
- Willingness to think creatively and solve complex problems in a fast-paced CDMO setting.
Nice To Haves
- Lean Manufacturing or Six Sigma experience preferred.
Responsibilities
- Lead cGMP CDMO technology transfer projects between customers and internal manufacturing teams for mRNA production.
- Manage tech transfer activities for NPIs from R&D/Process Development to GMP manufacturing, ensuring reproducibility and high quality.
- Provide technical oversight during technology transfer and manufacturing campaigns; assess and optimize process parameters for scalability.
- Design and execute experimental protocols; analyze data and prepare technical reports.
- Oversee GMP production and cleaning operations, ensuring compliance with regulatory standards and company requirements.
- Review and approve controlled documents, batch records, cleaning documentation, and GMP documentation (SOPs, deviations, CAPAs, change controls).
- Train, schedule, and supervise production and support staff; maintain training matrices and job descriptions.
- Coach and mentor manufacturing associates in process understanding, troubleshooting, and project management.
- Serve as a technical SME for internal teams and customers, supporting investigations and inquiries.
- Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Engineering, and R&D to meet production schedules and resolve issues.
- Drive continuous improvement initiatives using Lean Six Sigma and statistical tools; lead root cause analyses for critical investigations.
- Stay current with industry trends in modern manufacturing technologies (automation, disposable systems).
- Support audits, change controls, and Quality Risk Management programs.
- Perform other functions and duties as required
Benefits
- You have the potential to change, improve, and save lives around the world.
- You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
- We offer comprehensive medical plans and HSA/FSA options.
- Fertility & family planning assistance.
- A variety of additional optional benefits and insurance options, including pet insurance.
- Retirement contributions.
- Holidays & Paid Time Off.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
