GeneFab
Senior Process Engineer, MSAT
Alameda, CA · Senior · Full-time
Sponsorship not specifiedDetected 85 days ago
Process ImprovementProcurementGMPFDA RegulatoryCRISPRLeadershipCommunicationCollaborationMentoringWriting
About the role
- GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer, MSAT to serve as a critical technical authority within our Cell and Gene Therapy CDMO.
- This position is offered as a contract engagement with eligibility for conversion to full-time employment based on performance, business needs, and mutual alignment.
- GeneFab is committed to investing in high-performing contributors and views this role as a long-term addition to the organization.
Requirements
- Lead the identification, evaluation, procurement, and implementation of GMP manufacturing equipment required to enable platform capabilities and enhance existing capabilities.
- 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.
- Experience supporting IND, IMPD, or BLA filings with the ability to author and critically review CMC sections of regulatory submissions, working knowledge of ICH Q8, Q9, Q10, Q11, and Q12 guidelines.
- familiarity with analytical methods used to characterize cell and gene therapy products (i.e. identity, potency, purity, safety testing).
- Demonstrated ability to operate with a high degree of independence, define scope, manage competing priorities, and deliver results in a fast-paced, dynamic environment.
- Deep understanding of GMP regulations (21 CFR Parts 210/211/600/610, 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 capability with experience authoring SOPs, batch records, validation protocols, deviation reports, and regulatory submission content
- excellent cross-functional communication and collaboration skills.
Nice to have
- Bachelor's degree in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, or a closely related life sciences field required
- advanced degree (M.S. or Ph.D.) strongly preferred.
- Demonstrated expertise in advanced technology transfer, including hands-on leadership of complex tech transfer programs from process development through GMP manufacturing
- CDMO or CMO experience highly preferred.
- Experience in cell therapy (CAR-T, TIL, NK, or similar), gene therapy (AAV, lentiviral, or other viral vectors), or adjacent CGT modalities is highly preferred.
Apply directly at GeneFab →Create a free account for alerts like thisView GeneFab immigration profile
This listing is sourced directly from GeneFab's careers page and normalized into a canonical job model.