Associate Director/Director Process Dev. Tech Transfe

Location: United States (Bay Area)Therapeutic Focus: Immune Tolerance | Regulatory T Cells | Autoimmune Diseases | EpigeneticsEmployment Type: Full-timeAbout RegCellRegCell, cofounded by 2025 Nobel Laureate Shimon Sakaguchi, is a biotechnology company advancing a differentiated immune tolerance platform with the potential to transform the treatment of autoimmune diseases, with curative potential. The company is moving quickly to launch multiple clinical trials and has prioritized the development of a commercially viable CMC process for epigenetically reprogramming disease-causing T-cells into antigen-specific, functionally stable regulatory T cells.Position SummaryRegCell is seeking an Associate Director or Director of Process Development and Tech Transfer to lead the design, optimization, scale-up, and transfer of cell therapy manufacturing processes from process development into clinical and eventual commercial manufacturing. This individual will serve as the technical owner of upstream and/or downstream unit operations, partner closely with Manufacturing, Quality, Analytical Development, Regulatory Affairs, and CDMO partners, and play a critical role in ensuring processes are robust, scalable, and compliant with cGMP requirements. The level of hire (Associate Director vs. Director) will be commensurate with the candidate's experience.Key ResponsibilitiesLead process development activities for cell therapy manufacturing processes, including cell isolation, activation, expansion, harvest, formulation, and fill/finish, as applicable.Design and execute technology transfer plans to move processes from development into GMP manufacturing suites and/or external CDMO partners, including authoring and reviewing batch records, protocols, and technical transfer documentation.Drive process characterization, scale-up/scale-down model development, and design-of-experiments (DOE) studies to define critical process parameters (CPPs) and critical quality attributes (CQAs).Provide technical leadership and hands-on troubleshooting during engineering runs, process performance, and GMP manufacturing to resolve deviations and drive continuous improvement.3Author and review technical reports, risk assessments, process descriptions, and CMC sections of regulatory submissions (IND, IMPD, BLA) in partnership with Regulatory Affairs.Partner cross-functionally with Manufacturing, Quality Assurance, Quality Control, Analytical Development, Supply Chain, and Regulatory to ensure alignment on process robustness, comparability, and compliance.Manage relationships and technical oversight of external CDMO partners, including tech transfer packages, process characterization, and ongoing manufacturing support.Support equipment and facility design decisions, including single-use technology selection, closed-system processing, and automation strategy.Build, mentor, and manage a team of process development scientists and engineers as the group scales; set priorities, review data, and develop staff technical capabilities.Contribute to departmental budgeting, timeline planning, and risk management for the PD/Tech Transfer function.Ensure all activities comply with cGMP, safety, and quality standards, and support audit and inspection readiness.Required QualificationsPh.D. in cell biology, biochemical/chemical engineering, bioengineering, immunology, or a related field with 8+ years of relevant industry experience, or M.S. with 10+ years, or B.S. with 12+ years of relevant industry experience.Direct experience in process development and/or technology transfer for cell therapy products (e.g., CAR-T, Regulatory T cell, TIL, NK cell, iPSC-derived, or other autologous/allogeneic cell therapy platforms).Demonstrated experience leading tech transfer into GMP manufacturing, including authorship of technology transfer protocols/reports and direct support of engineering runs.Working knowledge of upstream and/or downstream unit operations relevant to cell therapy manufacturing (e.g., bioreactors, closed-system cell processing platforms, selection/activation, viral transduction, cell washing/concentration, formulation and fill/finish).Solid understanding of cGMP regulations, ICH guidelines, and regulatory expectations for cell and gene therapy CMC sections.Experience managing or collaborating closely with external CDMO/CMO partners.Strong data analysis, technical writing, and presentation skills; experience authoring regulatory and technical documents.Proven people leadership or mentorship experience, with the ability to build and develop a technical team.Excellent cross-functional collaboration and communication skills, with the ability to influence without direct authority.Preferred QualificationsExperience with DOE, statistical process control, and process characterization strategies to support BLA filings.Experience with single-use/closed-system automated cell processing platforms (e.g., CliniMACS Prodigy, Cocoon, Miltenyi, or similar).Prior experience supporting a successful IND, BLA, or comparable regulatory filing for a cell therapy product.Familiarity with comparability protocols and process validation lifecycle (Stage 1–3).