Senior Process Engineer, MSAT
About The Position
GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer to serve as a technical authority within its Cell and Gene Therapy CDMO. The role drives the establishment and maturation of GMP-ready platform processes that underpin internal manufacturing capabilities, with autonomy across process development, technology transfer, CMC strategy, and capability buildout. The position helps GeneFab develop scalable, regulatory-compliant manufacturing platforms that clients can use in IND filings and beyond. The successful candidate will translate scientific insight into robust manufacturing processes and build the infrastructure, capabilities, and frameworks needed to support GMP operations at scale. This is a contract engagement with eligibility for conversion to full-time employment based on performance, business needs, and mutual alignment.
Requirements
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or a closely related life sciences field.
- Minimum 6–8+ years of progressive experience in bioprocess development, MSAT, or GMP manufacturing within the biopharmaceutical or cell and gene therapy industry, commensurate with degree level.
- Demonstrated expertise in advanced technology transfer, including hands-on leadership of complex programs from process development through GMP manufacturing.
- Experience supporting IND, IMPD, or BLA filings, including the ability to author and critically review CMC regulatory submission sections.
- Working knowledge of ICH Q8, Q9, Q10, Q11, and Q12 guidelines.
- Deep understanding of GMP regulations, including 21 CFR Parts 210/211/600/610 and EU GMP Annex 1/15, as applied to advanced therapy manufacturing.
- Strong command of GMP documentation practices, including SOP authorship, batch record design, deviation management, and CAPA.
- Working knowledge of process characterization, design of experiments (DoE), and data-driven process optimization methodologies.
- Strong technical writing skills, including experience authoring SOPs, batch records, validation protocols, deviation reports, and regulatory submission content.
- Excellent cross-functional communication and collaboration skills.
- Ability to work independently, define scope, manage competing priorities, and deliver results in a fast-paced environment.
Nice To Haves
- An M.S. or Ph.D. degree.
- CDMO or CMO experience.
- Experience in cell therapy, such as CAR-T, TIL, or NK, gene therapy such as AAV or lentiviral vectors, or adjacent CGT modalities.
- Familiarity with analytical methods used to characterize cell and gene therapy products, including identity, potency, purity, and safety testing.
Responsibilities
- Lead GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations.
- Collaborate with Process Development to evaluate platform candidates, align on scalable manufacturing approaches, and prepare platforms to support CMC regulatory expectations.
- Lead technology transfer, validation, and lifecycle management initiatives.
- Author and review CMC Module 3 sections, development summaries, and supporting data packages for regulatory filings.
- Apply CMC expertise to align platform processes with FDA, EMA, and ICH Q8/Q9/Q10/Q11/Q12 guidance and support CMC content strategies.
- Lead advanced technology transfer activities, including transfers from external clients and internal process development groups.
- Develop and execute technology transfer plans covering process descriptions, batch records, comparability strategies, and acceptance criteria.
- Identify, evaluate, procure, and implement GMP manufacturing equipment to establish or enhance platform capabilities.
- Author, review, and approve SOPs, work instructions, master batch records, and other GMP-controlled process and equipment documents.
- Provide technical oversight during engineering and GMP manufacturing runs; assess reproducibility, identify performance gaps, and drive data-driven continuous improvement.
- Serve as the MSAT subject matter expert across Process Development, Quality, Regulatory, and Manufacturing teams.
- Mentor junior MSAT engineers and manufacturing specialists, and develop and deliver training on platform processes, equipment, and systems.
- Own, drive, and support quality management records, including deviations, CAPAs, change controls, SCARs, and effectiveness checks.
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What This Job Offers
Career Level
Senior
