QC Senior Specialist

QC Senior Specialist at Made Scientific QC Senior Specialist at Made Scientific in Blawenburg, New Jersey Posted in 9 days ago.

Type:

full-time

Job Description:

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. Operating from two U.S.-based manufacturing facilities, 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 Senior QC Specialist to support in-process and release testing for Cell and Gene Therapy (CGT) products. This role will also contribute to stability studies, microbiology, analytical, and reagent testing, ensuring high-quality and timely results to support manufacturing operations. Key Responsibilities

• Perform analytical and microbiological testing of CGT products, including sterility, mycoplasma, endotoxin, flow cytometry, cell count, potency assays, and other testing within a cGMP environment.
• Serve as a lead trainer and subject matter expert for analytical and microbiological methods, including flow cytometry, PCR, ELISA, sterility, and environmental monitoring, while mentoring junior staff.
• Coordinate GMP QC laboratory operations and inventory, ensuring compliance with internal policies and regulatory requirements.
• Troubleshoot and resolve issues impacting laboratory operations, test methods, equipment, or facility systems.
• Support method transfers and validation activities for methods, utilities, and equipment to ensure regulatory compliance.
• Review records for in-process monitoring, product release, and stability testing, ensuring adherence to GMP standards and procedures.
• Manage Quality System records (CAPAs, change controls, deviations, LIRs) and lead investigations of out-of-specification (OOS) results, proposing corrective actions.
• Oversee and execute environmental monitoring, method trending, Quality Management Review (QMR) reporting, and testing in Grade

A-D / ISO 5-7

environments.

• Implement, qualify, and optimize compendial methods to enhance processes and maintain regulatory compliance.
• Create, review, and approve QC documentation (SOPs, work instructions, test methods) to support continuous improvement.
• Support new product and technology introductions through cross-functional coordination and prioritization.
• Provide regular updates to management on progress, risks, and operational needs.
• Perform additional duties as assigned to support departmental objectives. 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 hands-on experience in microbiology (environmental monitoring, sterility, endotoxin, mycoplasma) and analytical methods (flow cytometry, PCR, ELISA).
• Extensive QC experience with a strong understanding of compendial methods and regulatory expectations.
• Ability and willingness to learn and perform new and complex assays in a dynamic environment.
• Ability to manage multiple priorities and thrive in a fast-paced, evolving environment.
• Flexibility to work varying schedules, including evenings, weekends, and shift-based schedules as needed.
• Strong organizational skills with the ability to work independently and as part of a team.
• Strong communication skills, including experience interacting with clients and regulatory authorities. Preferred Qualifications
• GMP experience in cell and gene therapy manufacturing.
• Experience with LIMS and analytical/microbiological methods including endotoxin, sterility, mycoplasma, PCR, flow cytometry, and method qualification/validation.
• Familiarity with FDA, EMA, ICH, USP, and cGMP regulations related to QC and cell-based manufacturing.
• Experience supporting laboratory investigations, deviations, CAPAs, and change control processes. 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.