Quality Operations Supervisor

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Princeton, NJ, US

5 days ago Requisition

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.
• 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,…