Join Our Crew

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.

Required Qualifications

• Ph.D. in Biological Sciences or related fields with 2+ years’ experience working within biologics process development and/or manufacturing under cGMP processes, or master's with 4+ years of relevant experience, bachelor's with 6-8 years relevant experience.
• Experience and working knowledge of T-cells or immunological cell therapies is required.
• Experience supporting allogeneic and/or autologous cell therapy process development, process scale-up, optimization and/or manufacturing required with process characterization and late-stage development is highly desired.
• Extensive experience with process development and process instrumentation engineering activities including, but not limited to, target cell isolation platforms (such as PBMC isolation), cell washing, cell culture expansion, and cell product cryopreservation.
• Experience with cell culture processing machinery, such as Sepax, LOVO, and CliniMACS Prodigy.
• Experience with functionally closed systems or early technology evaluations for large-scale autologous or allogenic CAR-T cell processing is highly desirable.
• Experience with and knowledge of analytical methods used in the characterization and understanding of cell therapy products. Flow cytometry experience is highly desired.
• Demonstrated ability for critical thinking and innovation, able to understand and communicate risks, and develop and execute contingency plans.
• Experience leading a project as a strong scientific leader, reviewing data and interpreting collective data sets and troubleshooting. Strong problem-solving skills are required.
• Strong written and verbal communication skills, with the demonstrated ability to work in a multidisciplinary team environment, with excellent communication and collaboration skills.
• Ability to coordinate and prioritize parallel tasks across multiple projects. Highly organized and efficient, able to work independently.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

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