Manager, Quality Control; Microbiology​/Analytical

Made Scientific is a leading U.S.

-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

MADE Scientific engineers, operations, and quality professionals work with our clients to translate groundbreaking treatments into the clinic. The novel therapeutics we focus on require constant innovation and creative thinking for clinical translation and subsequent GMP Operations to be successful. The state-of-the art MADE Scientific facility in Princeton, NJ, houses both process development labs and cleanroom spaces to support clinical manufacturing.

This role will be based in Princeton, NJ facility on site daily. We are expanding our team and seeking a QC Manager who will have a highly critical role and is responsible for managing the overall QC team that supports the manufacturing site (with a focus in Microbiology as well as Analytical).

The QC team is responsible for microbiological and analytical related testing of in-process samples, final product testing, qualification support, stability studies, as well as EMPQ, APS, and other contamination control and safety testing and support delivering high-quality, on-time results to meet client and manufacturing demands. The QC Manager is responsible for supporting the QC Director and the MADE site, acting as an SME during client and/or regulatory inspections and must have a strong background and understanding of FDA, USP, EU, and other governmental regulations or guidelines.

• Lead and manage a QC team with a minimum of 5 direct reports at different levels.
• Management and coordination of the QC team (both Microbiological and Analytical) laboratory testing program and scheduling to ensure timely testing and results, to support in-process, final product testing and release, stability studies, and monitoring of the critical utilities systems.
• Management and scheduling of the overall QC team to meet all new product qualifications, filings, and overall manufacturing schedule and needs.
• Coordinate and support program/method transfers, qualifications and/or validations as determined by client contracts.
• Ensure all QC employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports in career development.
• Work closely with cross‑functional teams (specifically) Analytical Development and PMO teams to support new and on‑going clients and programs.
• Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the QC laboratories.
• The QC Manager plays a critical role in ensuring that all materials, products, methods, and equipment are within specifications and ensures accurate and timely disposition of test results and compliance investigations.
• Ensure that QC lab test results which exceed the specification limits, are submitted as OOS/Deviations within the QMS and are investigated, and effective CAPAs are implemented as required.
• Oversight and support QC team for on time investigations and closure of Manage Quality System records (CAPA, Change Control, Deviations, LIR) and lead investigations of OOS results, proposing corrective actions.
• Manage and oversee…