We are inviting a hands-on and result driven formulation technical manager to join our team in supporting the growing need of technical transfer, process scale-up and clinical manufacturing for solid dosage forms.
Develop technical transfer (TT) documents working with formulation development scientists from lab to CMOs or between different manufacturing sites. Prepare TT strategy, plan and protocol. Oversee TT batch manufacturing and data analysis, and prepare TT report.
Prepare formulation process scale-up plan and protocol. Execute scale-up batch manufacturing, and communicate with formulation scientists to solve potential technical issues.
Work with formulation development scientists together to produce investigational drug products for clinical trial from early stage to late stage. Coordinate with CMOs to prepare manufacturing timeline, contracts and BMRs to make sure clinical supply timely.
Collaborate with other functional groups in pharmaceutical development, manufacturing plant, regulatory affairs, and clinical supply operation to push project forward smoothly from IND to NDA.
PhD or Master or Bachelor in Pharmaceutical related Sciences or Engineering. Bachelor with 8+ years, Master with 6+ years, or PhD with 3+ years of experience in pharmaceutical industry, with hands-on experience of drug product TT and/or manufacturing technical service, especially in oral solid dosage forms. Working experience in international pharmaceutical companies is preferred.
Solid understanding of cGMP knowledge and FDA/ICH guidelines is a must.
Hands-on clinical supply chain management experience is a plus.
Good communication and positive interpersonal skills. Good in writing and speaking both Chinese and English.