Manager, Production Operations & GMP

Maravai LifeSciences • San Diego, CA

7h • $115,000 - $125,000 • Onsite

About The Position

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies. At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai’s portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market. Your next role as a Miracle Maker 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.
• Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree