1.Direct Drug Sustance upstream manufacturing operation include but not limited to cell culture, microbial fermentation and primary recovery for biologics production 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.
5.Write/Review/Approve protocols, 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, Cell Line Development, Process Development, Down Stream Purification, 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 mammalian cell culture and microbial fermentation process, cell harvest, inclusion body, and refolding process. Ability in management, trouble shooting, and communication. Familiar with GMP production guideline. Fluent in English communication is preferred.
