Process Engineer II / III, MSAT

About GeneFab

GeneFab is a cell and gene therapy contract development and manufacturing organization (CDMO) located in Alameda, California. Formed in 2023, GeneFab supports clinical through pivotal-stage programs with process and analytical development, technology transfer, and cGMP manufacturing of cell therapies and lentiviral vectors. Built on a foundation in synthetic biology, GeneFab pairs deep technical expertise in genetic medicine development with the manufacturing capabilities needed to move therapies from the lab to patients.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.

Position Title: Process Engineer II / III, MSAT

Reporting To: Director, Manufacturing & MSAT

Department: Manufacturing Sciences and Technology

Location: Alameda, CA

Full Time

Job Description:

GeneFab is seeking a highly motivated Process Engineer II / III, Manufacturing Sciences and Technology (MSAT) to support technology transfer, process implementation, and ongoing GMP manufacturing of cell and gene therapy programs. This individual contributor role serves as a technical owner for internal and client processes as they move from development into GMP manufacturing and through the clinical lifecycle. The scope covers autologous and allogeneic cell therapies and viral vector manufacturing. The ideal candidate has hands-on experience with cell and gene therapy processes in a cGMP environment and is comfortable working in a fast-paced CDMO setting with broad responsibilities. The role works closely with Manufacturing, Process Development (PD), Analytical Development (AD), Quality Control (QC), Quality Assurance (QA), Supply Chain, and Facilities, as well as client technical teams, to deliver GMP readiness and reliable batch execution. Level will be determined by experience; at the III level, the engineer is expected to independently lead technology transfer workstreams and serve as the primary MSAT technical contact for assigned client programs.

Key Responsibilities:

Technology Transfer:

·         Lead or support technology transfer workstreams for internal and client programs, coordinating sending units (clients and PD) with receiving units (Manufacturing, QA, QC, AD, Supply Chain).

·         Develop and execute technology transfer plans, including gap assessments, facility fit analyses, and timelines aligned to program milestones.

·         Conduct process risk assessments (e.g., FMEA) and define mitigation strategies for transfer and scale-up activities.

·         Author and review process descriptions, bills of materials, material specifications, engineering run protocols and reports, and technology transfer reports.

·         Partner with Manufacturing to translate process descriptions into batch records and SOPs; review and approve batch records and related GMP documentation.

·         Plan and execute engineering and demonstration runs, and evaluate results against acceptance criteria to confirm GMP readiness.

Cell Therapy & Viral Vector Process Support:

·         Serve as MSAT process owner for autologous and allogeneic cell therapy processes (e.g., CAR-T, MSC, iPSC-derived), including cell selection, activation, transduction, expansion, harvest, formulation, and cryopreservation.

·         Implement and support closed and automated processing platforms (e.g., CliniMACS Prodigy, Sepax, Rotea, G-Rex, controlled-rate freezers).

·         Support viral vector process implementation across upstream (adherent and suspension culture, transient transfection) and downstream (clarification, nuclease treatment, chromatography, TFF, sterile filtration, fill) unit operations.

·         Contribute to the build-out of GeneFab’s internal manufacturing platforms, including single-use equipment selection, process fit, and scale-up.

Manufacturing Process Support:

·         Provide on-the-floor technical support during GMP manufacturing, including real-time troubleshooting of process and equipment issues.

·         Lead or support deviation investigations, root cause analyses, and CAPAs, including technical assessments of product impact.

·         Monitor and trend process data (process parameters, in-process results, yields) to detect drift and identify improvement opportunities.

·         Author and assess change controls for process, material, and equipment changes.

·         Train Manufacturing staff on new processes, equipment, and technologies.

Late-Phase & Commercial Readiness:

·         Support process characterization studies, including risk-based identification of critical process parameters (CPPs) and their relationship to critical quality attributes (CQAs).

·         Contribute to phase-appropriate control strategies, including in-process controls, proven acceptable ranges, and specifications.

·         Support process performance qualification (PPQ) planning and execution, and the establishment of continued process verification (CPV) programs.

Process Optimization & Continuous Improvement:

·         Evaluate manufacturing processes for opportunities to improve robustness, scalability, yield, and cost of goods.

·         Design and execute small-scale studies to support investigations and demonstrate proof-of-concept for proposed process changes.

·         Participate in continuous improvement initiatives across MSAT and Manufacturing.

Qualifications:

·         Bachelor’s or Master’s degree in Chemical Engineering, Bioengineering, Biomedical Engineering, Biotechnology, Cell/Molecular Biology, or a related field.

·         Process Engineer II: 3–5 years of relevant industry experience with a BS, or 1–3 years with an MS. Process Engineer III: 5–8 years with a BS, or 3–6 years with an MS.

·         Hands-on experience with cell therapy and/or viral vector manufacturing processes in a cGMP environment; experience across both is a plus.

·         Demonstrated experience in technology transfer, process implementation, and manufacturing support for clinical or commercial programs; CDMO experience preferred.

·         Experience with single-use systems and closed/automated cell processing equipment.

·         Working knowledge of cGMP regulations and FDA, EMA, and ICH guidance applicable to cell and gene therapy products.

·         Understanding of process lifecycle management from clinical through commercial, including process characterization, control strategy, PPQ, and CPV.

·         Proficiency in data analysis and statistical tools (e.g., JMP, Minitab), with the ability to interpret data in a phase-appropriate context and clearly communicate conclusions.

·         Strong technical writing skills, with experience authoring GMP documentation and investigation reports.

·         Strong communication and project management skills; comfortable working directly with client technical teams.

Working Conditions:

·         Onsite role based at GeneFab’s Alameda, CA facility, with work performed in office, laboratory, and GMP cleanroom environments.

·         Requires gowning for aseptic processing areas and regular presence on the manufacturing floor.

·         Work may involve handling of BSL-2 materials, cryogenic liquids (liquid nitrogen), and laboratory chemicals under established safety procedures.

·         Ability to stand for extended periods and lift up to 25 lbs.

·         Occasional evening, weekend, or holiday support may be required to align with GMP manufacturing schedules.

Compensation:

The anticipated base salary range for this position is $100,000 – $130,000. Final level and base salary will be determined based on relevant experience, skills, education, and internal equity.