Job Description
Process Development Scientist - Cell Therapy A growing biotechnology organization is seeking a Process Development Scientist to support the advancement of a late-stage cell therapy program. This role is responsible for developing and optimizing scalable, reproducible, and robust manufacturing processes to support clinical and future commercial production of a novel cell-based therapeutic. The position offers a dynamic and collaborative environment where you'll work cross-functionally to translate lab-scale methods into GMP-compliant manufacturing processes for human therapeutic use. Key Responsibilities • Design and execute experiments for process development and optimization, including cell expansion, purification, formulation, and cryopreservation. • Analyze data, interpret results, and contribute to technical documentation including protocols and study reports. • Identify and implement process improvements aimed at increasing efficiency, reducing cost, and ensuring product quality. • Collaborate with internal manufacturing teams and external partners to support technology transfer and GMP production. • Conduct process risk assessments (e.g., FMEA), and define or validate critical process parameters (CPPs). • Utilize QbD principles, including Design of Experiments (DoE) and statistical tools, to drive robust process design. • Remain current on trends and innovations in cell therapy, bioprocessing, and relevant regulatory developments. • Support internal knowledge sharing and, where appropriate, contribute to scientific communications. Qualifications • Degree in Biological Sciences, Bioengineering, Biochemical Engineering, or a related field. • PhD with 2+ years • MS with 8+ years • BS with 12+ years • Strong hands-on experience with cell culture, cell selection, and cell purification techniques. • Proven contributions to process development and successful technology transfer into GMP manufacturing. • Familiarity with analytical methods such as flow cytometry, PCR, ELISA, and cell counting/viability assays. • Strong problem-solving skills and experience troubleshooting cell-based manufacturing challenges. • Clear and concise communication skills, both written and verbal. • Ability to work independently and collaboratively in a fast-paced, cross-functional environment. Preferred Qualifications • Experience supporting or preparing regulatory filings (e.g., IND, BLA). • Knowledge of GMP regulations and regulatory expectations in the cell therapy space. • Proficiency with data analysis tools such as JMP, Minitab, or equivalent. 9907996 Apply tot his job