Responsibilities Include
- Contribute to the development of early and late-stage clinical manufacturing processes and commercial cell therapy manufacturing processes.
- Evaluate new technologies, develop novel cell therapy approaches, including cell sourcing, expansion, manipulation, and characterization. Contribute to the successful translation of novel cell therapies from early-stage research to clinical applications.
- Serves as a technical lead for process development projects, responsible for experimental design of process development studies, applying Quality by Design principles and Design of Experiment methodologies where appropriate.
- Optimize and scale-up cell culture processes, analyze data, and interpret results, author technical reports and derive standard operating procedures.
- Define process operating ranges, acceptable ranges for process understanding and performance optimization, perform gap analysis/failure mode effect and analysis (FMEA)
- Contributing to technology transfer, comparability, process characterization, process validation, and troubleshooting.
- Demonstrate strong oral and written communication skills, contribute to scientific conferences and presentations to share the knowledge with the broader scientific community.
- Collaborate with cross-functional teams, including analytical, pre-clinical, translational, quality assurance and regulatory, to establish robust and scalable manufacturing processes that comply with cGMP and regulatory requirements. Contributes to IND enabling studies.
- Author and review of technical documentation to support early-stage activities (development reports and supporting documentation for regulatory filings).
- Guide and mentor junior scientists for trouble shooting, deviation investigation, and product impact assessment for projects employing developed technology/processes.
- Maintain accurate and detailed laboratory notebook (including electronic notebook), summarize and present data in group and cross-functional meetings.