1.Direct Drug Substance downstream manufacturing operation include but not limited to primary recovery, and purification from cell culture and microbial fermentation to ensure achieving company objectives and department goals.
2.Anticipate internal and external tech transfer to ensure successful GMP manufacturing operations.
3.Assign and allocate resources (personnel, capitol, and equipment) to meet project timelines.
4.Participate in customer and regulatory audits. Ensure completing the improvement areas that were identified.
5.Write/Review/Approve protocol, batch records, reports and other documents including deviations, CAPA, and SOPs.
6.Collaborate with other cross-functional teams including but not limited to CMC, MSAT, Process Development, Formulation Development, Fill Finish, Quality, Engineering, Purchasing and Logistics.
7.Supervise, train and mentor direct reports and provide development opportunities. Ensure to attract and retain skilled talents.
Degree:BS, MS or Ph.D.
Major:Chemical Engineering, Biochemical Engineering, Biochemistry, Biotechnology, or closely related field.
Experience:BS degree with 10+ years, MS degree with 8+ years or Ph.D. with 6+ years of manufacturing experience in GMP biologic process. With 5+ years team management.
Age:NA
Skills:Experience in performing downstream activities in a GMP manufacturing facility. Familiar with various chromatographic and filtration process applied in biotechnology process for both mammalian and microbial system. Ability in management, trouble shooting, and communication. Fluent in English communication is preferred.
