Manager, Production Operations & GMP
$115k/y-$125k/y
TriLink BioTechnologies, part of Maravai LifeSciencesa day ago
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OnsiteFull-timeSenior
Summary
TriLink BioTechnologies, part of Maravai LifeSciences, is seeking a Manager, Production Operations & GMP to join their Process Development team in San Diego, CA. The role involves leading a team of technical experts to ensure efficient and compliant manufacturing operations.
About the Role
As a Manager, Production Operations & GMP, you will provide technical leadership for production processes, support technology transfers, and drive continuous improvement initiatives. Responsibilities include coaching manufacturing teams, optimizing workflows, overseeing cleanroom operations, and ensuring GMP compliance. You will collaborate with cross-functional teams to support new product introductions and investigations.
About You
Required:
- 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.
Preferred:
- Lean Manufacturing or Six Sigma experience.
- Experience with electronic quality systems and ERP platforms (e.g., NetSuite).
- Proven ability to manage and mentor teams, work cross-functionally, and drive strategic initiatives.
Benefits
- Potential to change, improve, and save lives around the world.
- Opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
- 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.
TriLink BioTechnologies, part of Maravai LifeSciences
TriLink BioTechnologies, a Maravai LifeSciences company, is a global leader in nucleic acid and mRNA solutions. TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its patented CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors, and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans. For more information, visit trilinkbiotech.com
San Diego, CA