YOUR TASKS AND RESPONSIBILITIES
- Ensures appropriate analytical methods are used to assess stability of new products and review methodology study related documents, including but not limited method development report, validation/ verification/transfer protocol/ report, etc.
- Oversees the analytical development work performed by analytical contractors or CMOs
- Oversees the analytical stability studies performed by analytical contractors or CMOs
- Ensures appropriate analytical methods are used to assess stability of new products and review methodology study related documents, including but not limited method development report, validation/ verification/transfer protocol/ report, etc.
- Ensures stability studies are appropriate to establish the new product
- shelf-lifes and are performed in compliance with Bayer policies and China regulatory requirements
- Review the stability results and stability reports for NPDs and confirm/extend post market shelf-lives products, report OOT/OOS and support risk assessment.
- Provide on-site technical leadership to CMO to overcome, in a fast and efficient manner, analytical and technical challenges
- Review analytical results and report.
- Review raw material specifications and ensure compliance with regulatory
- Requirements Is responsible to set formulations, raw material and finished product specifications in Product Data Visibility (PDV).
- Supports CMC documentation draft and review for NPDs, TT projects and post launch change products.
- Provides on-site support for post launch products, including but not limited impurity study design, method development, pre-validation, lab investigation, informal stability test, etc.
WHO YOU ARE
- Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +5 years of prior experience in a technical role within the pharmaceutical or related industry is preferred. Master's degree or higher with +3 years' experience, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent.
- Knowledge of regulatory guidelines (e.g., FDA, EMA, CFDA) and industry best practices related to analytical development and stability testing.
- Knowledge in analytical techniques such as HPLC, GC, LC-MS, dissolution testing, and spectroscopy. Microbiological experience is a plus.
- Good analytical, problem-solving skills and attention to detail, with the ability to learn and apply new concepts quickly.
- Good in data analysis software and tools commonly used in the lab field.
- Good communication and interpersonal skills, with the ability to work effectively in a team environment.
- Good English communication skills, both written and verbal. Other languages are a plus.
- Detail-oriented with the ability to maintain accurate documentation and records.
- Strong desire to learn and grow within the lab field.