Senior Process Engineer, MSAT
Requirements- 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.
$72 - $89 an hour
