GeneFab is seeking a highly motivated and technically accomplished Senior Process Engineer, MSAT to drive the establishment and maturation of GMP-ready platform processes for cell and gene therapy CDMO. The role requires a critical technical authority with a high degree of autonomy across complex, cross-functional initiatives spanning process development, technology transfer, CMC strategy, and capability buildout.
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.
Benefits
- Contract / Temporary employment
- Opportunity for conversion to full-time employment based on performance, business needs, and mutual alignment
