製程開發

A successful candidate will be expected to have a solid background in cell therapy processes, scale-up, experience working in or supporting a cGMP-regulated environment, as well as sound technical knowledge of manufacturing processes for engineered immune cell therapies.

RESPONSIBILITYIES

Design and execute phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study

Design and execute DP process-enabling studies including formulation, fill/finish, cryopreservation, thawing, and in-use compatibility study of candidate cell therapy product.

Testing new manufacturing technologies and platforms in partnership with R&D.

Develop robust, scalable, directed-differentiation processes platform.

Be responsible for preparation of protocols, reports, test methods, and SOPs.

Review and discuss analytical results and conclusions both orally and in writing.

Work in a team-based structure and interface with research and process development departments.

Maintain and ensure safe laboratory environment and work practices.

Ensure timely completion of testing and tasks as assigned.

QUALIFICATIONS AND REQUIREMENTS

Master with 8+ yrs. of relevant experience in immune cell culture, differentiation, expansion, formulation process.

Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required.

Hands-on experience with common cell therapy laboratory equipment and technology platforms (i.e. primary NK cells, iPSC-derived cell types, etc.)

Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required.

Deep understanding of biologics industry process development strategies and best practices as applied from early development.

Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic.

Excellent presentation skills, written and verbal.

Occasional weekend work may be required.

Understanding of GMP regulations is preferred.