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, 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.
Design and implement process monitoring and control strategies, conducting process characterization studies, and identifying critical process parameters to ensure product quality and consistency.
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 CMC enabling studies.
Author and review of technical documentation to support early-stage activities (development reports and supporting documentation for regulatory filings) as well as draft manufacturing documentation to support tech transfer.
Guide and mentor junior scientists for trouble shooting, deviation investigation, and product impact assessment for projects employing developed technology/processes.
Contribute to the strategic planning and decision-making related to process development initiatives, ensuring the timeline, budget and quality standards are met
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 4+ years’ experience (Associate Principal Scientist) or 6+ years (Principal Scientist) working within biologics process development and manufacturing under cGMP processes, or masters with 6-7 years of relevant experience, bachelors with 8-10 years relevant experience.
Experience and working knowledge of T-cells or immunological cell therapies are required.
Biotech industry experience supporting allogeneic and /or autologous cell therapy process development/process scale-up /optimization/manufacturing; experience with process characterization and late-stage development is highly desirable.
SME for process development and process instrumentation engineering activities including, but not limited to, target cell isolation platforms, automated cell washing, electroporation systems, culture expansion, cryopreservation.
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.
Experience with non-viral gene editing techniques (e.g., CRISPR) in primary T cells with instrumentation and methods that can be implemented in manufacturing is a plus.
Good working knowledge of cGMP manufacturing of biological process and ICH regulations. Experience drafting manufacturing documentation and supporting documentation for regulatory filings is strongly desired. Experience with clinical phase appropriate regulatory requirements in manufacturing from early to registrational trials is a plus.
Demonstrated ability for critical thinking and innovation, able to understand and communicate risks, and develop and execute contingency plans.
Experience leading a team as a strong scientific leader, reviewing and interpreting the collective data sets and troubleshooting.
Ability to develop strong partnerships as part of a team and work collaboratively with cross-functional groups, including members of the CMC, Preclinical, Discovery teams, and project management, to meet project deliverables.
Ability to coordinate and prioritize parallel tasks across multiple projects. Highly organized and efficient, able to work independently.
Strong problem-solving skills are required. Project management experience is a plus.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Strong team orientation and passion for continuous self-development.
Detail-oriented with excellent problem-solving, technical writing and verbal communication skills.
Strong team orientation and passion for continuous self-development.
Experience in industry or in a startup industrial setting is preferred.

Average Compensation: $125,000

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