Job Description
Company Overview
Wu Xi Biologics is a world-class biologics services provider that accelerates and transforms discovery, development, and manufacturing in the fast-growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU, Asia, and Israel. It currently employs over 10,000 people and provides services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.
Job Title: QC Separations Team Lead
About the Role:
This role will lead technical projects and activities in the QC Separations group at Wu Xi Biologics. The site is focused on start-up activities involving commissioning and qualification aligned with project timelines.
Responsibilities:
1. Support execution of strategy and business planning processes, ensuring cross-functional collaboration.
2. Design, construction, and commissioning of the new facility for the production of drug substance.
3. Develop a Biologics QC separations product-testing team (HPLC, CE, and c IEF) including planning, recruiting/hiring, coaching/mentoring, and training.
4. Provide analytical support for Biologics manufacturing while ensuring compliance with c GMP guidelines/regulations, company SOPs, and safety regulations.
5. Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations.
6. Team Lead and line Manager for QC Separation Scientist and Associate Scientist.
7. Serve as a technical expert supporting non-conformances, investigations, change controls, deviations, and CAPAs.
8. Develop and maintain high-level scientific achievements; expected to be a point of contact for project coordination.
9. Seek opportunities for continuous process improvements/improved operational excellence.
10. Ensure tasks associated with start-up and routine operations are carried out in a safe manner.
11. Support Risk Assessments for projects and business innovation initiatives from a Separations perspective.
12. Ability to work in a team environment and independently as required.
Requirements:
* Technical Competencies: Experience working in a QC function in a greenfield context of similar size and scale is ideal. Previous experience handling regulatory inspections from FDA, EMA, etc., and GMP audits from clients, as well as internal Quality Assurance is advantageous.
* Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including HPLC, CE, and c IEF to support QC release and stability testing in a GMP-environment according to USP, EP, and Ch P requirements is preferred.
* Experience: More than 8 years' experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
* Knowledge: Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.
* Qualifications: University degree in related science/quality discipline required.
* Behavioural Competencies: Strong leadership competencies with demonstrated management skills. Excellent interpersonal, verbal, and written communication skills. Able to think critically and demonstrate troubleshooting and problem-solving skills.
Benefits:
Bonus, Canteen, Life Assurance, Paid Holidays, Parking, Pension, VHI.