Director, QC Microbiology

Job Description

Job Description

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

Position Summary

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.

Key Responsibilities

Leadership and Oversight:  

• 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.  

Operational Excellence (OE) & Lean Lab Management:  

• 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. 

Release Assays and Testing: 

• 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 schedules maintaining compliance with GMP and regulatory standards ensuring seamless project execution 

• Maintain a state of operational readiness and proactively monitor and adjust lab activities to ensure testing milestones and client commitments are met without compromising on quality. 

• Drive efficient, scalable testing processes for client projects, ensuring on-time delivery of quality results. 

• Take full accountability for ensuring that all release assays are completed accurately and on schedule, meeting project timelines set by both clients and internal teams. 

Regulatory Compliance and Documentation: 

• Ensure all QC activities, testing, and documentation comply with GMP, and relevant regulatory requirements (FDA, EMA etc.). 

• Ensure comprehensive and accurate documentation of QC activities, maintaining a high level of detail , accuracy and data integrity in testing results. 

• Provide clear, concise reports on QC testing outcomes, deviations, and overall progress to senior management, clients, and regulatory agencies when necessary. 

• Maintain traceability and audit-readiness for all QC documentation and testing procedures. 

• Oversee the accurate and timely preparation of essential documentation, including test protocols, methods, CoAs ensuring data integrity and audit readiness. 

• Lead and participate in internal audits, client audits, and regulatory inspections, ensuring readiness and adherence to quality expectations: serve as a key QC representative during internal and external audits. 

  Cross Functional Leadership and Collaboration:

• Communicate proactively with clients, providing updates, resolving issues, and ensuring transparency in QC activities and performance. 

• Support technology transfer and method onboarding aligning and collaborating with QC Tech Transfer Lead 

• Collaborate cross-functionally with QC Tech Transfer Lead, Manufacturing, Quality Operations, Analytical Development, and Program Management to ensure seamless integration of QC deliverables with project timelines and client expectations. 

• Foster a culture of innovation, continuous learning, and regulatory excellence within the QC team. 

• Collaborate with senior leadership to align quality and compliance initiatives with overall strategy and client satisfaction. 

Required Qualifications 

• Bachelor’s (10+ yrs), Master’s (8+ yrs), or Ph.D. (5+ yrs) in a scientific discipline (e.g., Biology, Microbiology, Biochemistry), with progressive experience in GMP Quality Control or analytical labs—including 3–5+ years in a leadership role, ideally within a CDMO or regulated biotech environment. 

• Extensive hands-on experience with Flow Cytometry, PCR, Microbiology, Rapid Sterility Testing, and Bioassays. 

• Proven track record in overseeing release assays in a cell therapy manufacturing environment. (e.g., CAR-T, iPSC, TILs). 

• Strong understanding of GMP regulations and regulatory guidance for ATMPs. 

• Strong experience in implementing and managing lean lab operations and delivering operational excellence in a fast-paced, client-driven setting. 

• Solid understanding of client-facing dynamics in a CDMO environment, with a focus on project timelines, regulatory compliance, and quality. 

• Demonstrated success in building and leading high-performing, technically skilled QC teams. 

• Excellent leadership and people management skills, with the ability to inspire and guide teams to achieve high standards in testing, efficiency, and operational performance. 

• Willingness to travel between facilities and work flexible hours, including evenings, weekends, and shift-based schedules as operational needs dictate. 

• Excellent organizational skills, with the ability to manage multiple priorities, ensuring on-time delivery, compliance and adapt to evolving demands while maintaining a positive, solution-oriented attitude. 

• Strong communication skills, with the ability to effectively interact with internal and external stakeholders including regulatory bodies. 

• Ability to effectively negotiate and build collaboration amongst individuals. 

• Experience with digital QC systems (e.g., LIMS, ELN). 

• Familiarity with regulatory submissions and global inspections (FDA, EMA) 

Preferred Qualifications

• Experience in driving continuous improvement initiatives within a growing environment.