Director, Process Development

Position Summary

Cellares is seeking an innovative and highly motivated Director to lead enterprise client programs within the Process Development team. The candidate will have extensive experience in cell therapy manufacturing, personnel oversight and client relationship management. This individual will interface across many parts of the company and with customers to translate existing client drug product manufacturing processes onto the Cell Shuttle manufacturing platform.

The successful candidate will be responsible for managing and developing scientists and research associates, as well as supporting technology transfer and ongoing research and development activities. Extensive experience in experimental design, process development, process characterization, MSAT and cell/gene therapy manufacturing are required. The ideal candidate will be well acquainted with developing scalable processes and transferring them from the development space into manufacturing.

Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

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

Cellares’ total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.