Director, Process Development

• Developing and leading the Enterprise Programs team within the PD department
• Managing tech transfer and process development activities to enable regulatory filing
• Serving as the company’s internal subject matter expert with regards to cell therapy manufacturing questions associated with all Enterprise Programs
• Assuming responsibility for tracking and planning resource allocation, budgets, headcount and continuous team, process and technology improvements
• Developing best practices, templates, and standards for transitioning processes from development into characterization and, ultimately, manufacturing
• Planning the process development team’s work for the quarters to come with clearly defined goals and resourcing plans
• Performing gap analyses and translating existing manual and/or automated processes onto the Cell Shuttle platform
• Performing and supporting in the execution of verification, validation, and performance qualification
• Authoring standard operating procedures, protocols, and batch records for the manufacturing of Enterprise Program cell therapies
• Working with our Analytical Development team to assess and quantify the quality of cell therapy manufacturing process steps in meeting Enterprise Program client requirements
• Authoring high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings

• PhD, M.S. or B.S. in biological sciences (Molecular Biology, Immunology, Genetics)
• Excellent organizational and communications skills and strong ability to lead and work with individuals across all levels in the organization
• 4+ years of experience in the cell and gene therapy manufacturing or process development space, with at least two years in an industry setting.
• Extensive experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+)
• Experience with both autologous and allogeneic cell therapy manufacturing workflows in preclinical, clinical and/or commercial environments
• Experience representing companies externally, with strong client relationship management skills
• Experience with managing and growing process development teams and processes
• Strong experimental design and troubleshooting skills, able to distill complex scientific information into simple and actionable final reports
• Experience working in a GMP environment and familiarity with quality requirements
• Demonstrated experience in process optimization, characterization and tech transfer
• Excellent data analysis skills and experience with a variety of scientific software applications
• Great verbal and written communication skills and the ability to interpret, summarize, and present scientific results in a clear, concise, accurate manner to both technical and non-technical audiences
• Must be able to travel up to 15% of the time
• Self-awareness, integrity, authenticity and a growth mindset

• Experience interfacing with the FDA
• PhD / post-doctoral experience in the gene/cell therapy field
• Experience authoring CMC sections for IND, IMPD and NDA
• Proven track record of utilizing management and process improvement tools (daily management, problem solving & root cause analysis tools, value stream mapping etc.) to meet and exceed strategic business objectives

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.