Quality Operations Supervisor

Job Description

Job Description

Quality Control Operations Supervisor

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.

We are seeking a Quality Control Operations Supervisor join our team. This is a full-time, onsite position based in Princeton, New Jersey, reporting to the Director, Quality Compliance. 

Position Summary

The QC Operations Supervisor is a hands-on leadership role responsible for executing and overseeing daily Quality Control Operations in the Analytical and Microbiological laboratories in a cGMP environment. The Supervisor will be fully qualified on assays, actively perform and troubleshoot testing, and provide technical guidance while managing staff scheduling, training, and workload distribution. This role ensures QC testing in support of cell therapy products is executed on time, to the highest quality standards, and in compliance with cGMP. The Supervisor will support Princeton and Newark sites, providing direct quality control oversight and operational support across both locations.

Key Responsibilities 

Laboratory Testing & Technical Support

• Perform analytical and microbiological testing (e.g., Flow Cytometry, PCR, ELISA, Sterility, Endotoxin, Bioburden) as part of routine QC operations across sites.
• Support ramp-up of new assays and technologies to meet evolving client and regulatory needs.
• Maintain assay qualifications and act as a technical resource for troubleshooting methods, equipment, and operational issues across sites.

Leadership & Oversight

• Supervise QC Specialists, including scheduling, training, mentoring, and performance management.
• Balance hands-on testing responsibilities with oversight of team activities to ensure timely support for in-process, release, and stability testing.
• Coordinate with Manufacturing, QO, QC Management, and cross-functional teams to allocate resources and resolve operational challenges.

Client Support

• Support multiple client programs by ensuring project-specific quality documentation, records, and deliverables are reviewed and maintained in compliance with standards and regulatory requirements.
• Assist with client audits and inspections at Princeton and Newark, preparing documentation, coordinating logistics, and ensuring timely responses to client requests.
• Participate in technical transfers and cross-site initiatives by supporting documentation review, process alignment, and communication between teams.

Compliance & Quality Systems

• Ensure laboratory compliance with SOPs, company policies, and applicable regulatory standards (FDA, EMA, USP, ICH).
• Ensure integrity and compliance of electronic data systems (e.g., LIMS) with regulatory expectations.
• Support method transfers, qualifications, and validations for assays, equipment, and utilities.
• Review and approve QC records, ensuring accuracy, compliance, and data integrity.
• Lead or support investigations, deviations, CAPAs, and Change Controls.
• Monitor and report trends in environmental monitoring, analytical results, and lab performance metrics.

Continuous Improvement & Inspection Readiness

• Contribute to continuous improvement of QC processes, including authoring and approving SOPs and training materials.

• Support audit and inspection readiness and serve as SME during client and regulatory interactions.

Required Qualifications

• Bachelor’s degree in a scientific discipline (Biology, Chemistry, Microbiology, or related) with 5–7 years of QC or GMP lab experience, including prior supervisory or leadership experience; Master’s degree with 3–5 years relevant experience preferred.
• Proven technical proficiency in QC modalities relevant to cell therapy, including analytical assays (e.g., flow cytometry, PCR, ELISA, potency, identity, viability, immunophenotyping) and microbiological assays (e.g., sterility, endotoxin, bioburden, environmental monitoring).
• Demonstrated ability to troubleshoot assays, instrumentation, and laboratory systems. Experience with laboratory data systems, including LIMS and instrument/equipment qualification and compliance software.
• Prior supervisory experience in a GMP laboratory setting.
• Proven ability to lead change, drive culture, and influence across functions in a fast-paced, regulated environment.
• Ability to manage schedules and resources while remaining directly engaged in laboratory testing.
• Excellent organizational, communication, and problem-solving skills.
• Flexibility to work shift-based schedules (including evenings, weekends, and holidays as needed).

Preferred Qualifications

• B.S in a relevant scientific discipline (advanced degree preferred).
• Experience with cell and gene therapy QC testing in clinical or commercial settings.
• Demonstrated success leading investigations and supporting CAPA/Change Control processes.
• Experience working in a multi-project, multi-client CDMO environment, including managing method transfers between clients/sites, supporting client audits and regulatory inspections, and ramping up new assays.
• Familiarity with global regulatory requirements and expectations for advanced therapy products.

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/ISO7-8 facility, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals

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.