Principal Scientist/Associate Director
Principal Scientist/Associate Director, Purification Process Development\
We are seeking an independent, experienced, and self-motivated senior level Scientist to be a key member of a dynamic and fast-paced organization. The successful candidate will provide hands-on leadership to develop stage appropriate purification processes used for pre-clinical and clinical production of therapeutic proteins.
- Lead the downstream process development team to design, execute, and document laboratory studies for purification process development and for protein production at various scales, including hands-on bench activities.
- Pplay an active role in process technology transfer and supporting tox and clinical manufacturing at contract development and manufacturing organizations (CDMOs).
- The successful candidate must be a goal-oriented team player with excellent troubleshooting and communication skills and adaptive to a timeline driven work environment.
- Ph.D in Biochemistry, Biochemical Engineering, or related field with 12+ yrs industry experience in developing protein/antibody purification processes to support pre-clinical and clinical stage programs. Experience in production of antibody drug conjugate is highly preferred.
- Experience in leading a purification process development team and overseeing GMP manufacturing is required.
- Both hands-on experience and scientific knowledge in modern protein purification techniques (chromatography, clarification/filtration, ultrafiltration/diafiltration, and conjugation) are required.
- Hands-on experience in programming and operating chromatography systems, TFF systems, as well as column packing and evaluation at various scales are also required.
- Working knowledge and hands-on experience in implementing basic analytical techniques (gel electrophoresis, HPLC and protein assays) for protein quantitation and characterization are required.
- Experience in purification process characterization, scale-up, technology transfer to CDMO, including drafting development reports, production batch records, protocols etc., to support clinical manufacturing is highly desired.
- Experience in process development and optimization using statistical tools (DOE and data analysis) is a plus.
- Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.
- Excellent communication, organization, and collaborative skills are essential.