Principal Scientist or Manager, Formulation Development and GMP Manufacturing

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We are inviting a hands-on and result-driven formulation development and GMP manufacturing scientist or manager to join our team in supporting the growing need of formulation process scale-up, technical transfer and GMP manufacturing for solid oral dosage forms.

Responsibilities: 

  1. Develop formulation process scale-up and technical transfer (TT) documents working with formulation development scientists from lab to CMOs or between different manufacturing sites. Prepare process optimization study, TT strategy, plan and protocol. Oversee and execute batch manufacturing and data analysis, and prepare TT report and process study report. Solve potential formulation and manufacturing technical issues.
  2. 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.
  3. 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.

Qualifications:

  1. PhD or Master or Bachelor in Pharmaceutical related Sciences or Engineering. Bachelor with 8+ years, Master with 5+ years, or PhD with 3+ years of experience in pharmaceutical industry, with hands-on experience of formulation development, TT and/or manufacturing technical service, especially in oral solid dosage forms.
  2. Working experience in international pharmaceutical companies is preferred.
  3. Solid understanding of cGMP knowledge and CFDA/FDA/ICH guidelines is a must.
  4. Hands-on clinical supply experience or supply chain management is a plus.
  5. Good in writing and speaking both Chinese and English.