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Job Description
**Job Description:**
QC Separations Lead, Associate Director
WuXi Biologics is a world-class biologics services provider with global clients in the biopharmaceutical and healthcare industries. As a QC Separations Lead, Associate Director, you will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence, and quality within the business.
**Key Responsibilities:**
- Lead the management of separations product-testing teams, including HPLC, CE, and cIEF.
- Develop and implement local QC strategies and business plans, aligned closely with the global QC function.
- Collaborate with senior leaders to ensure work practices and targets are achieved in line with business objectives.
- Support the design, construction, and commissioning of new facilities for drug substance production.
- Develop and build a world-class biologics QC separations product-testing team, including planning, recruiting, coaching, mentoring, and training.
- Provide analytical support for biologics manufacturing, ensuring compliance with cGMP guidelines, company SOPs, and safety regulations.
- Interact with internal and external partners, clients, and inspectors, maintaining high quality standards and services.
- Communicate and collaborate with QC functional teams and other departments to support lab start-up and routine operations.
- Lead groups to meet pre-determined goals and budgets, streamlining workflow and maximizing operational efficiency while maintaining full compliance.
- Develop and maintain high-level scientific achievements, serving as a point of contact for project coordination, including email and client meetings.
- Introduce new technologies and seek opportunities for continuous process improvements and operational excellence.
- Ensure QC staff receive appropriate GMP training and maintain compliance and high-quality standards.
- Create a safety culture, enforcing safety measures and ensuring QC staff work in a safe environment.
- Enhance collaborations by sharing knowledge and experiences across WuXi Biologics global sites.
- Be flexible to take on additional tasks and responsibilities at the discretion of the Engineering Director.
- Act as a role model for the Engineering function and the wider organization in adherence to WuXi corporate core values and local site shared commitments/behaviours.
**Technical Competencies:**
- Establishing a QC function and building a team in a 'greenfield' context of similar size and scale.
- Handling regulatory inspections from FDA, EMA, etc., and GMP audits from clients, as well as internal Quality Assurance.
- Preparing, reviewing, and approving technical documents, including method protocols, qualification and validation protocols, and reports.
- Technical expertise in tech transfer, validation, and troubleshooting biologics product-testing methods, including HPLC, CE, and cIEF.
- Experience with LIMS, Empower, ECM, Master Control, Trackwise, or similar systems.
- Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project.
- Management and supervision of personnel, with particular attention to schedules and shifting priorities.
- Demonstrated leadership skills, including experience in a Quality Control/GMP environment.
- Knowledge of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.
- Qualifications: University degree in a related science/quality discipline required.
- Desired qualifications: Ph.D. with 5+ years of experience or Masters with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related fields.
**Behavioral Competencies:**
- Excellent interpersonal, verbal, and written communication skills.
- Ability to think critically and demonstrate troubleshooting and problem-solving skills.
- Self-starter and self-motivated, with organized 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.
- Ability to thrive in a dynamic and fast-paced environment.
WuXi Biologics is a premier provider of biologics services, with a mission to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.