Position: Head of Peptide GMP Service
Department: Chemistry Service Unit - WuXi AppTec
Location: WuHan, China
Build, lead and manage the work activities of WuXi’s Peptide GMP Service in WuHan site, responsible for the operation and expansion Peptide API GMP manufacturing. Provide technical direction, GMP oversight, and scientific expertise for all activities within group’s operations
Key Activities and Responsibilities:
- Provide leadership to the overall peptide GMP service unit. Organize and lead the Production department, QC, QA, related Supply chain, Facility and Logistic personnel in the new GMP facility.
- Oversee day-to-day operations.
- For GMP manufacturing: Create and foster a solid GMP environment that meets the requirements of the SFDA, ICH, FDA and EMA guidelines and standards. Ensure that facilities are properly maintained and remain in compliance with all regulatories.
- Direct the implementation and execution of manufacturing policies and practices across the group. Ensure that facilities are properly maintained and remain in compliance with FDA standards.
- Participate as required in the development of groups plans to streamline the manufacturing and supply chain processes for GMP API l production.
- Set up the appropriate internal processes to create and maintain all regulatory and quality documentation.
- Assume responsibility for estimating, managing and allocating annual operating budget that are related to peptide groups operation.
- Ensure all the high risks are identified and properly managed within manufacturing operation activities, provide technical and compliance expertise to deviation investigations, self or third party inspection.
- Ensure the operational performance standards for quality, production scheduling, safety, and capacity planning.
Competences, Skills and Qualification:
- PhD or Master Degree in a life science or related discipline, with Peptide background preferred
- A minimum of 10 years pharmaceutical industry or biopharmaceutical sector
- Experience, with at least over 5 years’ team management role.
- Prior experience in GMP peptide field is a must. Experience should include general peptide discovery, process development, scale-up and cGMP peptide manufacturing
- Excellent communication skill, both in Chinese and English.
Good work ethics.