1.Direct Fill-Finish operation including but not limited to drug product formulation, aseptic filling, labeling and packaging 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 to complete the improvement areas that were identified.
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 Fill Finish Development, CMC, MSAT, 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 in aseptic filling operation. 5+ years team management.
Age:NA
Skills:Demonstrated knowledge of Biological GMP process and regulatory requirements in Drug Product production. Extensive industrial experience in management and execution of Fill-Finish production and audit process as well as trouble shooting and communication skills. Fluent in English communication is preferred.
