Job Description
Quality Control Specialist II at Made Scientific Quality Control Specialist II at Made Scientific in Princeton, New Jersey Posted in 5 days ago.
Type:
full-time Job Description:
About Made Scientific Made Scientific is a U.S.-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. Headquartered in Princeton, New Jersey, Made Scientific combines the agility of a specialist CDMO with the deep technical expertise to deliver reliable and scalable solutions, supported by their long-term strategic backer, GC Corporation, a global leader in the pharmaceutical and biotechnology sectors. About the Role 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. We are expanding our team and seeking a QC Specialist II to support in-process and release testing for Cell Therapy products. The role will also contribute to stability studies, microbiology, analytical, and reagent testing, delivering high-quality, on-time results to meet manufacturing demands. Work Schedule Requirement This role operates on a Monday - Thursday schedule, 3rd shift (11:00 PM - 9:00 AM). Key Responsibilities Perform analytical and microbiological testing of CT (Cell Therapy) products, including Sterility, Mycoplasma, Endotoxin, Flow Cytometry, Cell Count, Potency, and other testing in a controlled cGMP environment. Serve as lead trainer and subject matter expert on analytical methods, including Flow cytometry, PCR and ELISAs, Sterility, Environmental Monitoring, while mentoring junior staff. Coordinate GMP QC lab operations and inventory, ensuring compliance with company policies and applicable requirements. Troubleshoot and resolve issues impacting laboratory operations, test methods, equipment, or facility systems. Coordinate method transfers and validation of methods, utilities and equipment as applicable to ensure regulatory compliance. Review records for in-process monitoring, product release, and stability testing, ensuring adherence to GMP and applicable standards and procedures. Manage Quality System records (CAPA, Change Control, Deviations, LIR) and lead investigations of OOS results, proposing corrective actions. Oversee and execute environmental and method trending, QMR presentations, and Environmental Monitoring Testing in Grade A-D/ISO 5-7
areas. Implement, qualify, and optimize pharmacopoeia methods to enhance processes and ensure regulatory compliance. Create, review, and approve QC documents (SOPs, work instructions, testing methods) to ensure continuous improvement. Support new product and technology introductions, managing cross-functional coordination and prioritization. Update management on progress, roadblocks, and needs to ensure smooth project execution. Perform other duties as assigned to support department goals. Required Qualifications Master's Degree with 2+ years of experience in GMP environment, focusing on microbiology (Environmental Monitoring, Sterility, Endotoxin, Mycoplasma) and analytical methods (Flow Cytometry, PCR) or Quality Control, OR a bachelor's degree with 3+ years of relevant experience. In depth knowledge and hands-on experience with microbiology methods, aseptic techniques and analytical assays, including Flow Cytometry, PCR, ELISAs. Extensive QC experience with a comprehensive understanding of compendial methods and regulatory guidance. Ability and willingness to learn and perform new and complex microbiological and analytical assays as part of the evolving needs of the team. 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. Preferred Qualifications GMP experience in Cell Therapy. Experience with LIMS, Endotoxin, Sterility, mycoplasma, PCR, Flow Cytometry, and method qualification/validation, including supporting method transfer activities. Familiarity with FDA, EMEA, ICH, USP, GMP
guidelines, and cGMP regulations related to QC labs and cell-based product manufacturing. Proven ability to support lab investigations, deviations, CAPAs, and change controls. Physical Requirements Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for a CNC/ISO8
facility, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.
