Associate Director of Potency Assay
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 220,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network.
- Lead a team of cell based potency assay scientists to support analytical activity of drug substance (vaccine) technical transfer and process characterization in the lab.
- Involved in the design, planning, and set-up of the vaccine potency assay lab.
- Be responsible for the highest quality analytical support for internal and client’s samples, while ensuring compliance with FDA/ICH guidelines/regulations, company SOPs, and safety regulations.
ESSENTIAL JOB FUNCTIONS:
- Serve as a technical expert to transfer the method from client and verify the cell-based potency methods (qPCR based) for vaccines to support drug substance process development and PC.
- Develop/build a world-class cell-based potency assay analytical team including planning, recruiting/hiring, coaching/mentoring, and training for staffs and group leaders.
- Play a leading role in project management interaction with internal and external clients such as Process Development and Quality Control.
- Ensure potency staff receive appropriate safety training and maintain compliance and high quality standards
- Prepare, review, and approve technical documents including assay fit for purpose reports and analytical reports, etc.
- Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
- Continuously improve potency lab quality systems/documents, enhance data quality, and deliver high quality results
- Create a safety culture, enforce safety measures and ensure potency lab staffs working in a safe environment
- Ability to work in a team environment and independently as required