About Made Scientific 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.
Position Summary:
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.
Key Responsibilities:
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 execution of environmental monitoring and method trending, QMR presentations.
Ensure the site and department objectives are met.
Update management on progress, roadblocks, and needs to ensure smooth project execution.
Perform other tasks assigned to support clients and regulatory needs per program.
Required Qualifications:
Master’s Degree with 5+ years of experience in GMP environment, focusing on microbiology (Environmental Monitoring, Sterility, Endotoxin, Mycoplasma) and analytical methods (Flow Cytometry, PCR) OR a bachelor’s degree with 7+ years of relevant experience.
Must have at least 3+ years direct management experience.
Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.
Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
Must be team-oriented and have the demonstrated ability to work cross-departmentally throughout the manufacturing site.
Advanced data integrity practices and knowledge.
Advanced knowledge of cGMP's, FDA, USP, EU regulations and guidelines, as related to manufacture of QC labs and cell-based product manufacturing.
Ability to thrive in a face-paced, dynamic environment, manage multiple priorities, and adapt to evolving demands.
Willingness to work flexible hours, including evenings, weekends, and shift-based schedules as operational needs dictate.
Highly organized, team-oriented, and able to work with minimal supervision while maintaining a positive attitude.
Skilled in interacting with clients and health authorities, with strong verbal and written communication.
Proven ability to support lab investigations, deviations, CAPAs, and change controls.
Physical Requirements:
Ability to perform the essential job functions consistent safely and successfully with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
Must be willing to be gown qualified and work in BSL-2 lab/CNC/ISO7/ISO8 facility.
Must be able to lift and carry up to 30 lbs.
Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool.
Must be willing to sit or stand for extended periods.
Must be willing to work with cell-based products, chemicals or hazardous materials.
Work Environment:
Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments.
May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials.
Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements.
May require occasional work outside of normal business hours to support maintenance needs or facility emergencies.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.
Equal Employment Opportunity Statement:
Made Scientific is proud to be an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace. We make employment decisions based on qualifications, merit, business needs, and job requirements without regard to race, color, religion, creed, sex, pregnancy, childbirth or related medical conditions, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship status, or any other status protected by applicable federal, state, or local law. Made Scientific is committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, unless doing so would create an undue hardship.
