Job Description
QC In Process Team Lead Summary:
Lead a technical projects team in QC In Process group at Wu Xi Biologics, responsible for ensuring analytical support for Biologics manufacturing, compliance with cGMP guidelines, and collaboration with cross-functional teams.
Job Description:
As the QC In Process Team Lead, you will be responsible for leading a team of scientists and associate scientists in the QC In Process group at Wu Xi Biologics. The team is focused on start-up activities involving commissioning and qualification aligned with project timelines.
- Support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
- Develop and maintain high levels of scientific achievements for the company.
- Communicate, collaborate, and cooperate with MFG and QC functional teams and other departments to support site operations.
- Manage In-process team shift rota.
- Team Lead and line Manager for QC In Process Scientist and Associate Scientists, providing guidance and direction, performance management, training plan through scheduling, and direct 1-2-1 with the team.
- Serve as a technical expert supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs.
- Develop and maintain high level of scientific achievements for the company.
- Seek opportunities for continuous process improvements/improved operational excellence.
- Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner.
- Support Risk Assessments for projects and business innovation initiatives.
Key requirements for the role include:
- 8+ years of experience working within a Quality Control environment.
- Experience working in the Biologics industry.
- Previous experience managing and leading a small team.
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems.
- Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project.
- Management/supervision of personnel with particular attention to schedules and shifting priorities.
- Knowledge of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.
Wu Xi Biologics is a world-class biologics services provider offering a range of services from discovery through to commercialization. The company has sites/offices in China, US, EU, and Asia, employing over 10,000 people worldwide.
About Wu Xi Biologics:
Wu Xi Biologics is a premier provider of biologics services, offering a world-leading open access technology platform. The company enables clients to research, develop, and manufacture drugs from the concept phase to commercial manufacturing.
Requirements:
- University degree in related science/quality discipline required.
- 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.
- Self-starter and self-motivated; organized with good attention to detail.
- Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
- Results-oriented, with the ability to manage multiple priorities in a short period of time.