Director, Process Development

Responsibilities

• 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

Requirements

• 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

Nice to have

• 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