Director, QC Microbiology

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Exempt - FT Manager Eagleville, PA, US

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 Director, Quality Control Microbiology to join our team. This is a full-time, onsite position based in East Norriton, PA.

The Director of Quality Control Operations will lead and manage the Quality Control Operations team at Made Scientific managing all activities related to the release assays for cell therapy products. This role requires hands‑on experience and technical expertise in Flow Cytometry, PCR, microbiology, rapid sterility testing, and bioassays. The Director will be on‑site leading a team of QC professionals, ensuring the highest quality standards for GMP‑compliant testing, while meeting client needs and regulatory requirements actively engaging and executing day‑to‑day quality operations.

• Lead, mentor, and develop a high‑performing QC Operations team, ensuring alignment with internal quality standards and regulatory requirements (GMP, FDA, EMA).
• Provide strategic direction and operational leadership for all QCO functions, with a focus on timely, compliant, and high‑quality release testing.
• Oversee day‑to‑day QC laboratory operations, ensuring accurate execution of assays and fostering a culture of accountability, timeliness, technical excellence, and continuous improvement.
• Serve as a technical and operational leader for release assays including Flow Cytometry, PCR, Microbiology, Rapid Sterility Testing, and Bioassays.
• Manage staffing, workload balancing, and performance management, ensuring QC team members are motivated, empowered, and aligned with business goals and a quality‑centric culture.
• Lead by example in performing key tests, troubleshooting issues, and providing real‑time technical guidance to the team on assays such as Flow Cytometry, PCR, Microbiology, Rapid Sterility Testing, and Bioassays.

• Champion lean lab principles, standardizing workflows and driving process efficiencies to support scalability and agility in QC operations
• Foster a culture of OE in QC by continuously evaluating and improving lab processes to eliminate non-value-added activities, reduce turnaround times, and improve cost-effectiveness
• Ensure the QC lab operates at peak efficiency, with minimal downtime, reducing bottlenecks and ensuring resources (staff, equipment, reagents) are utilized effectively while maintaining a state of compliance
• Identify areas for process optimization within the QC testing workflows, driving improvements in efficiency and scalability while maintaining high-quality standards.

• Oversee execution and troubleshooting of GMP‑compliant release assays (Flow Cytometry, qPCR, Microbial Methods, Rapid Sterility, Bioassays, etc.) , ensuring timely and accurate data reporting.
• Ensure timely delivery of high‑quality test results in alignment with production and client release…