Quality and Regulatory Affairs Engineer, iPSC Cell Therapy

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience's hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

This role is embedded directly in Science's Biohybrid Cells program, which is actively transitioning from R&D-stage workflows to cGTP-compliant, GMP-like operations in support of IND filing. You will own quality control of the cell line end-to-end, from incoming material and process controls through lot release, and serve as the primary QA presence on the Cell team.

This is a hands-on role requiring deep familiarity with both the regulatory framework for cellular products (21 CFR Part 1271, IND-enabling requirements) and the practical reality of running QC in a live cell processing environment. You will work closely with the Biohybrid scientific team, external CMO partners, and the broader QARA function to build and execute quality systems that are phase-appropriate, auditable, and positioned for clinical-stage scale-up.

• Own QC testing documentation and lot release for cell banks including identity, viability, sterility, mycoplasma, endotoxin, and genomic integrity testing
• Author and execute batch records; ensure complete traceability from incoming material through cryopreservation
• Establish and maintain Certificate of Analysis (CoA) templates, and out-of-specification (OOS) investigation procedures
• Manage incoming QC for biological raw materials, reagents, and consumables; execute and document incoming inspection per approved procedures
• Define and implement in-process controls
• Investigate deviations, non-conformances, and OOS results; lead root cause analysis and CAPA implementation

• Serve as the QA subject matter expert for 21 CFR Part 1271 (cGTP) and applicable GMP requirements for combination product cellular components
• Support IND-enabling activities: author or review the quality sections of the IND submission, including CMC narrative, process description, and QC testing plan for the cell line
• Build and maintain the Cell QMS:
  
  - SOPs, controlled forms, training records, deviation management, and CAPA
• Lead the QAU audit and inspection schedule for Cell operations; conduct internal audits and prepare the program for regulatory inspections
• Manage the supplier qualification program for iPSC-specific vendors, including biological reagent suppliers, specialized equipment vendors, and contract service providers
• Oversee document and record control specific to the iPSC program; ensure GDP compliance across all batch records, logbooks, and controlled documents

• Own the environmental monitoring program for controlled PD suite operations: sampling schedule, alert/action limits, trend analysis, and response to excursions
• Maintain QA oversight of equipment qualification and calibration records for the iPSC processing suite; coordinate IQ/OQ/PQ for new or modified equipment
• Review and approve facility-related SOPs including gowning, sanitation, biosafety cabinet certification, cleanroom entry, and contamination response procedures
• Partner with the Biohybrid team to assess and document facility readiness as controlled operations scale toward clinical-grade cell processing

• Serve as the QA interface with external partners (e.g. CDMO) performing master cell bank establishment or downstream manufacturing activities; draft and maintain quality agreements
• Review and approve CMO batch records, test reports, and deviations; conduct or participate in supplier audits and qualification activities
• Manage material transfer agreements (MTAs) with quality terms; ensure incoming materials from CMO partners meet defined acceptance criteria before use in controlled operations

• Develop and deliver cGTP and GMP training programs for iPSC operations staff; ensure documented competency prior to initiation of controlled activities
• Contribute to broader QARA team functions including QMS maintenance, CAPA, management review, and the internal audit…