Director, Process Development

Cellares

Cellares

Administration
San Francisco, CA, USA
Posted on Monday, April 17, 2023
Position Summary
Cellares is seeking an innovative and highly motivated Process Development Director with extensive experience in cell therapy manufacturing to join the team. This individual will interface across many parts of the company and with customers to develop novel products used in the cell therapy and gene therapy world. The role requires a hands-on leader who is passionate about the cell and gene therapy space and strong at building high performing teams and processes.
The successful candidate will be responsible for managing and developing a team of scientists and research associates, as well as supporting technology transfer and ongoing research and development activities. Extensive experience in experimental design, process development, cell and gene therapy, method scale up, and problem solving are required. The ideal candidate will be keen on developing scalable processes and optimizing workflows to meet and exceed performance and quality metrics.
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

  • Hiring, onboarding, developing, and leading the process development team
  • Manage tech transfer and process development activities to enable regulatory filing
  • Serving as the company’s internal subject matter expert with regards to any cell therapy manufacturing questions
  • Developing best practices, templates, and standards for experimental design, troubleshooting, and root cause analysis
  • Planning the process development team’s work for the quarters to come with clearly defined goals and resourcing plans
  • Developing and optimizing cell therapy manufacturing processes on various types of equipment and automated systems
  • Perform gap analyses and translate manual processes onto the Cellares Cell Therapy 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 cell and gene therapies
  • Shaping the approach and policies for developing and establishing analytical methods
  • Assay development to assess and quantify the quality of cell therapy manufacturing process steps executed within the company, such as flow cytometry based assays, cytotoxicity assays, PCR and endotoxin analysis
  • Author high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings

Requirements

  • PhD or equivalent 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 and clinical environments
  • 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, USP, and FDA regulations
  • Demonstrated experience in optimization, scale up, and technology 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.
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.