Cellares
Director, Process Development
South San Francisco, CA · Director
Sponsorship not specified$170k-$240kDetected 407 days ago
Data AnalysisProcess ImprovementGMPFDA RegulatoryCRISPRMolecular BiologyResearchExperimental DesignAnimal StudiesCommunicationProblem Solving
About the role
- 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.
- 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
- Excellent organizational and communications skills and strong ability to lead and work with individuals across all levels in the organization
- Strong experimental design and troubleshooting skills, able to distill complex scientific information into simple and actionable final reports
Requirements
- 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
- 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
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
- 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.
- Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale.
- 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.
Compensation
- 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.
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