Associate Scientist, Process Development
On-sitePhiladelphia, Pennsylvania, United States
Job Summary
Execute process development experimental plans, design and execute Design of Experiments (DoE) studies to support process improvement and evaluate critical quality attributes, and assist in transferring product candidates to CDMOs for cGMP clinical manufacturing. Develop and review electronic Batch Records, accurately capture data to ensure integrity and protocol compliance, and identify new technologies to improve manufacturing outcomes such as reduced costs and increased throughput. Coordinate with internal stakeholders and external partners to schedule and track clinical patient material shipping, troubleshoot associated issues, and maintain laboratory material inventory. Requires a B.S. with 3+ years or M.S. with 1+ years in process development under cGMP, experience with T-cell therapies, and up to 10% domestic travel.
Required Qualifications
- B.S. with 3 + years or M.S. with 1 + years' experience within process development and manufacturing under cGMP processes
- Previous experience and working knowledge of T-cells or immunological cell therapies
- Experience with cell therapy manufacturing scale up, technology transfer, and process development and optimization
- Good working knowledge in cGMP manufacturing of biological process and ICH regulations
- Good coordination and communication skills
- Highly organized and efficient, able to work independently
- Strong problem-solving skill
- Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization
- up to 10% domestic travel
- occasional weekend and overtime work
Desired Qualifications
- Experience in process automation
- Experience in flow cytometry and cell-based bioassays
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