Senior Process Engineer, MSAT

Senior Process Engineer, MSAT

GeneFab Alameda, California, United States

About this position

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

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.

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 individual will drive the establishment and maturation of GMP-ready platform processes that form the foundation of our internal manufacturing capabilities, operating with a high degree of autonomy across complex, cross-functional initiatives spanning process development, technology transfer, CMC strategy, and capability buildout.

This role is pivotal in shaping GeneFab’s ability to deliver scalable, regulatory-compliant manufacturing platforms that clients can leverage directly in their IND filings and beyond. The Senior Process Engineer will translate scientific insight into robust manufacturing processes while building the infrastructure, capability, and frameworks necessary to support GMP operations at scale. The ideal candidate thrives in a fast-paced, entrepreneurial environment, is energized by building capabilities from the ground up, and brings the independent judgment to drive programs forward.

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.

What you'll do

• Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations.
• Collaborate closely with Process Development to evaluate platform candidates, align on scalable manufacturing approaches, and ensure all platforms are structured to support CMC regulatory expectations for regulatory filings.
• Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
• Contribute to CMC regulatory submissions by authoring and reviewing CMC module 3 sections, development summaries, and supporting data packages for applicable regulatory filings.
• Apply deep CMC knowledge to ensure internal platform processes align with current regulatory guidance (FDA, EMA, ICH Q8/Q9/Q10/Q11/Q12) and support the development of CMC content strategies.
• Serve as an MSAT lead for advanced technology transfer activities, including transfers from external clients and inbound transfers from internal process development groups.
• Develop and execute comprehensive tech transfer plans including process descriptions, batch records, comparability strategies, and acceptance criteria.
• Lead the identification, evaluation, procurement, and implementation of GMP manufacturing equipment required to enable platform capabilities and enhance existing capabilities.
• Author, review, and approve SOPs, work instructions, master batch records, and other GMP-controlled documents for processes and associated equipment.
• Provide technical oversight during engineering and GMP manufacturing runs to evaluate process reproducibility, identify performance gaps, and drive data-driven continuous improvement initiatives.
• Function as the MSAT subject matter expert (SME) across cross-functional teams spanning Process Development, Quality, Regulatory and Manufacturing.
• Provide technical mentorship and guidance to junior MSAT engineers and manufacturing specialists; develop and deliver training materials for platform processes, equipment, necessary systems.
• Own, drive, and support quality management records, including but not limited to deviations, CAPAs, change controls, SCARs and effectiveness checks.

Qualifications

• 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.
• 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 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.
• 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.
• 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; 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.
• 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.

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

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.

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 individual will drive the establishment and maturation of GMP-ready platform processes that form the foundation of our internal manufacturing capabilities, operating with a high degree of autonomy across complex, cross-functional initiatives spanning process development, technology transfer, CMC strategy, and capability buildout.

This role is pivotal in shaping GeneFab’s ability to deliver scalable, regulatory-compliant manufacturing platforms that clients can leverage directly in their IND filings and beyond. The Senior Process Engineer will translate scientific insight into robust manufacturing processes while building the infrastructure, capability, and frameworks necessary to support GMP operations at scale. The ideal candidate thrives in a fast-paced, entrepreneurial environment, is energized by building capabilities from the ground up, and brings the independent judgment to drive programs forward.

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.

What you'll do

• Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations.
• Collaborate closely with Process Development to evaluate platform candidates, align on scalable manufacturing approaches, and ensure all platforms are structured to support CMC regulatory expectations for regulatory filings.
• Serve as a technical lead for technology transfer, validation, and lifecycle management initiatives.
• Contribute to CMC regulatory submissions by authoring and reviewing CMC module 3 sections, development summaries, and supporting data packages for applicable regulatory filings.
• Apply deep CMC knowledge to ensure internal platform processes align with current regulatory guidance (FDA, EMA, ICH Q8/Q9/Q10/Q11/Q12) and support the development of CMC content strategies.
• Serve as an MSAT lead for advanced technology transfer activities, including transfers from external clients and inbound transfers from internal process development groups.
• Develop and execute comprehensive tech transfer plans including process descriptions, batch records, comparability strategies, and acceptance criteria.
• Lead the identification, evaluation, procurement, and implementation of GMP manufacturing equipment required to enable platform capabilities and enhance existing capabilities.
• Author, review, and approve SOPs, work instructions, master batch records, and other GMP-controlled documents for processes and associated equipment.
• Provide technical oversight during engineering and GMP manufacturing runs to evaluate process reproducibility, identify performance gaps, and drive data-driven continuous improvement initiatives.
• Function as the MSAT subject matter expert (SME) across cross-functional teams spanning Process Development, Quality, Regulatory and Manufacturing.
• Provide technical mentorship and guidance to junior MSAT engineers and manufacturing specialists; develop and deliver training materials for platform processes, equipment, necessary systems.
• Own, drive, and support quality management records, including but not limited to deviations, CAPAs, change controls, SCARs and effectiveness checks.

Qualifications

• 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.
• 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 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.
• 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.
• 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; 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.
• 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.

The pay range for this role is:
150,000 - 185,000 USD per year(GENEFAB - ALM)#J-18808-Ljbffr