QC Manager, Analytical

About Made ScientificMade 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 SummaryMade 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 Analytical methods as well as Microbiology. The QC team is responsible for analytical and microbiological testing of in-process samples, final product testing, qualification support, stability studies, EMPQ, APS, and contamination control activities. This role supports the QC Director, serves as a subject matter expert during client and regulatory inspections, and ensures 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 analytical and microbiology functions.• Oversee analytical testing activities, including flow cytometry, PCR, cell counts, viability, potency, and other cell-based assays.• Manage QC laboratory testing programs and scheduling to ensure timely execution of in-process, final product, stability, and utility monitoring activities.• Align QC team scheduling and resources to support product qualifications, regulatory filings, and manufacturing needs.• Coordinate and support method transfers, qualifications, and validation activities in alignment with client requirements.• Ensure QC personnel are trained and qualified; provide performance evaluations and support career development.• Collaborate cross-functionally with Analytical Development, PMO, and other teams to support client programs.• Develop and manage SOPs, forms, and test methods to ensure compliant QC laboratory operations.• Ensure materials, products, methods, and equipment meet specifications and support accurate and timely disposition of 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 support environmental monitoring programs, method trending, and Quality Management Review (QMR) reporting.• Ensure site and departmental objectives are achieved.• Provide regular updates to leadership on progress, risks, and resource needs.• Perform additional duties as required to support client programs and regulatory needs.Required Qualifications• Master’s degree with 5+ years of experience in a GMP environment, or Bachelor’s degree with 7+ years of relevant experience.• Strong background in analytical methods (flow cytometry, PCR, potency assays) with working knowledge of microbiology (environmental monitoring, sterility, endotoxin, mycoplasma).• Minimum of 3+ years of direct management experience.• Demonstrated leadership skills, including setting direction, driving execution, and fostering a collaborative team environment.• Advanced knowledge of analytical techniques, data analysis, and foundational microbiology principles.• Strong understanding of data integrity 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 environment, manage multiple priorities, and adapt to evolving demands.• Flexibility to work varying schedules, including evenings, weekends, and shifts as needed.• Strong communication skills, including experience interacting with clients and health 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.