QC Manager, Microbiology
2 days ago
Princeton
About Made Scientific Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors. Position Summary Made Scientific's engineers, operations, and quality professionals work with clients to translate groundbreaking treatments into the clinic. The novel therapeutics we support require constant innovation and creative thinking to enable successful clinical translation and GMP manufacturing. Our state-of-the-art Princeton, NJ facility includes both process development labs and cleanroom space to support clinical manufacturing. We are expanding our team and seeking a QC Manager who will play a critical leadership role overseeing the Quality Control team, with a focus on both Microbiology and Analytical testing. This individual will manage QC operations supporting manufacturing, ensuring high-quality, compliant, and timely testing to meet both client and production needs. The QC team is responsible for microbiological and analytical testing of in-process samples, final product testing, qualification support, stability studies, EMPQ, APS, and contamination control programs. The QC Manager will support the QC Director, serve as a subject matter expert during client and regulatory inspections, and ensure compliance with FDA, USP, EU, and other applicable regulatory standards. Key Responsibilities • Lead and manage the QC team, including a minimum of five direct reports across microbiology and analytical functions., • Oversee QC laboratory testing programs and scheduling to ensure timely execution of in-process, final product, stability, and utility monitoring activities., • Manage team scheduling and resource allocation to support new product qualifications, regulatory filings, and manufacturing demands., • Coordinate and support method transfers, qualifications, and validation activities in alignment with client requirements., • Ensure all QC personnel are properly trained and qualified; provide performance evaluations and support career development., • Collaborate cross-functionally with Analytical Development, PMO, and other teams to support ongoing and new client programs., • Develop and manage SOPs, forms, and methods to ensure compliant QC laboratory operations., • Ensure all materials, products, methods, and equipment meet specifications and support accurate and timely disposition of test results., • Ensure out-of-specification (OOS) results are documented as deviations within the QMS, investigated appropriately, and supported by effective CAPAs., • Oversee timely investigation and closure of quality system records, including CAPAs, change controls, deviations, and laboratory investigation reports (LIRs)., • Manage and oversee environmental monitoring programs, method trending, and Quality Management Review (QMR) reporting., • Ensure departmental and site objectives are met., • Provide regular updates to leadership on progress, risks, and resource needs., • Perform additional duties as required to support client programs and regulatory requirements. Required Qualifications • Master's degree with 5+ years of experience in a GMP environment, or Bachelor's degree with 7+ years of relevant experience, preferably in life sciences., • Strong background in microbiology (e.g., environmental monitoring, sterility, endotoxin, mycoplasma) and analytical methods (e.g., flow cytometry, PCR)., • Minimum of 3+ years of direct management experience., • Demonstrated leadership and team management skills, including setting direction, executing goals, and fostering a collaborative environment., • Advanced knowledge of microbiological techniques, including media preparation, incubation conditions, organism identification, and enumeration., • Strong understanding of data integrity principles and practices., • Advanced knowledge of cGMP, FDA, USP, and EU regulatory requirements related to QC and cell therapy manufacturing., • Ability to work cross-functionally and effectively across departments., • Ability to thrive in a fast-paced, dynamic environment while managing multiple priorities., • Flexibility to work varying schedules, including evenings, weekends, or shifts as needed., • Strong communication skills with experience interacting with clients and regulatory authorities., • Experience supporting investigations, deviations, CAPAs, and change controls. Required Degree • M.S. in Life Sciences or a related field with 5+ years of experience, or, • B.S. in Life Sciences or a related field with 7+ years of experience. Physical Requirements • Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations., • Flexibility to work in controlled environments, including gowning for CNC/ISO8 facilities., • Ability to lift up to 25 lbs., • Ability to perform physical tasks such as bending, standing, and working with cell-based products or chemicals.
Page 2