QC Manager / Senior Scientist (Raw Materials & Compendial)

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform the discovery, development, and manufacturing of biologics to benefit patients worldwide. Summary: The QC Manager/ Senior Scientist (Raw Materials and Compendial) will be responsible for the management and oversight of the Raw Materials and Compendial Testing QC laboratory. This role requires a strong understanding of cGMP regulations and will be responsible for ensuring the laboratory maintains compliance with all relevant regulatory requirements. The QC Manager/ Senior Scientist will oversee the testing of raw materials, in-process samples, and finished products, and will be responsible for the investigation of any out-of-specification (OOS) results. This position will be responsible for the supervision of QC personnel, method development, and validation, and will be accountable for the timely and accurate completion of all testing activities. Responsibilities: * Manage and oversee the Raw Materials and Compendial testing laboratory. * Ensure the laboratory maintains compliance with cGMP regulations and all relevant regulatory requirements. * Oversee the testing of raw materials, in-process samples, and finished products. * Investigate any out-of-specification (OOS) results. * Supervise QC personnel, providing guidance and training. * Develop and validate analytical methods. * Ensure the timely and accurate completion of all testing activities. * Perform routine and non-routine analysis of raw materials and drug product. * Perform method validation and transfer activities. * Review and approve QC documentation (e.g., test results, logbooks, etc.). * Author and review SOPs, protocols, and reports. * Participate in investigations and CAPA activities. * Maintain laboratory equipment and instrumentation. * Perform other duties as assigned. Qualifications: * Bachelor's or Master's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field). * Minimum of 8+ years of experience in a pharmaceutical or biotechnology QC laboratory. * Strong knowledge of cGMP regulations and compendial testing requirements. * Experience with raw material and compendial testing methods. * Experience with method development and validation. * Experience with OOS investigations. * Experience with HPLC, GC, and other analytical techniques. * Strong leadership and management skills. * Excellent communication and interpersonal skills. * Ability to work independently and as part of a team. Preferred Qualifications: * Experience with Empower software. * Experience with LIMS. * Experience with USP, EP, and JP compendial methods. * Experience in a biologics manufacturing environment. Benefits: * Comprehensive medical, dental, and vision insurance * Paid time off (vacation, sick, and holidays) * 401(k) plan with company match * Life and disability insurance * Employee assistance program * Professional development opportunities * Relocation assistance (if applicable)