Bayer-posted 4 months ago
$149,000 - $223,000/Yr
Berkeley, CA
5,001-10,000 employees
Educational Services

The primary purpose of the Cell Therapy Manufacturing Science Expert is to focus on end-to-end process and manufacturing readiness and implementation of cell therapy products and technologies from development to manufacturing within the Berkeley CT GMP environment. This position acts as a crucial link between CMC and manufacturing capabilities. This role requires a deep understanding of cell therapy processes and GMP requirements, strong project management skills, and the ability to collaborate effectively with various stakeholders to meet and drive project milestones and deliverables.

  • Lead Technology Transfer Projects: Oversee the development, transfer, and commercialization of cell therapies to the CT MOD facility, establishing an integrated technology transfer and technical support system and process.
  • Act as Connector: Serve as a pivotal liaison between CMC&T and Manufacturing Biologics to ensure seamless technology transfer, implementation and lifecycle management (LCM) support of cell therapies into CT-MOD.
  • Cross-Functional Collaboration: Collaborate with CMC&T, Quality Assurance, and Manufacturing teams to align on project goals and deliverables related to cell therapy processes as part of process and GMP/NPI readiness workstreams.
  • Documentation Management: Develop and maintain comprehensive project documentation, including (but not limited to): process descriptions, risk assessments, reports, SOPs, plans, protocols, and reports to support technology transfer and lifecycle management support activities for cell therapies.
  • Risk Management: Identify potential risks associated with cell therapy processes and implement mitigation strategies, including owning and conducting risk assessments for process, raw materials or other aspects of the process.
  • Training and Support: Conduct training sessions for manufacturing personnel on new cell therapy processes and technologies, ensuring training reflects process requirements and compliance.
  • Lifecycle Management and Process Performance Monitoring: Provide on floor technical support. Lead and build sustainable technical support team and process. Monitor and analyze process performance post-transfer and throughout regular production, making recommendations for continuous improvement in cell therapy production.
  • Technical Expertise: Provide technical expertise for engineering, conformance/validation and GMP runs, troubleshooting, and investigations, serving as a subject matter expert on cell therapy technology transfer processes and best practices.
  • Degree in chemical engineering, bioprocessing science, biological sciences or similar field with biotechnology industry experience in a biotechnology or pharmaceutical company, or similar industry environment.
  • Strong experience in the cell therapy modalities (pluripotent stem cells, allogenic cell therapy and/or iPSCs), manufacturing process development, tech transfer, and cGMP manufacturing.
  • Significant hands-on experience in developing, optimizing, implementing, and qualifying cell culture processes according to industry best practices.
  • In-depth knowledge of biologics processes, technology development, and comprehensive understanding of GMP requirements in CMC development and manufacturing, with preferred focused with cell therapies.
  • Strong stakeholder management and engagement skills, with a proven ability to build and maintain relationships across various organizational levels.
  • Proficiency in data analysis and problem-solving techniques.
  • Strong analytical and problem-solving skills, with a track record of implementing innovative solutions in product development.
  • Excellent verbal and written communication skills, with proficiency in negotiation and conflict resolution at all levels, with internal and external stakeholders (i.e. health authorities).
  • Degree in chemical engineering, bioprocessing science, biological sciences or similar field with 15+ years of experience with PHD, or 17+ years of experience with Masters, or 19 + years of experience with a Bachelors.
  • Health care
  • Vision
  • Dental
  • Retirement
  • PTO
  • Sick leave
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