Cellares · 2 days ago
Director, Process Development
South San Francisco, CA
Full-time
Onsite
Lead/Staff, Director/Executive
$170K/yr - $240K/yr
4+ years expCellares is an Integrated Development and Manufacturing Organization (IDMO) focused on mass manufacturing cell therapies. The Director of Process Development will lead enterprise client programs, manage scientists, and support technology transfer while ensuring the development of scalable processes for the Cell Shuttle manufacturing platform.
BiotechnologyLife ScienceManufacturingMedicalTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
Highly subsidized Medical, Dental, and Vision Plans
401(k) Matching
Free EV Charging
Onsite lunches
Stock options
Company
Cellares
Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.
51-200 employees
H1B Sponsorship
Cellares has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (2)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$355MKey Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M
Leadership Team
Fabian Gerlinghaus
Co-Founder & CEO
Omar Kurdi
Co-Founder and President
Recent News
Morningstar.com
2026-01-12
GlobeNewswire
2026-01-12
Company data provided by crunchbase