Director of Quality Control

Made Scientific; Princeton (NJ); On-site; USD 150,000 - 180,000; Full time

Job summary

Made Scientific is seeking a Director of Quality Control Operations in Princeton, NJ. This leadership role involves managing Quality Control activities for cell therapy products, ensuring compliance with GMP and overseeing a skilled QC team. Candidates should possess extensive experience in key testing methodologies and demonstrate strong leadership in a fast-paced environment.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 10+ yrs (Bachelor), 8+ yrs (Master), or 5+ yrs (Ph.D.) in GMP Quality Control.
• Extensive hands-on experience with major testing methods.
• Proven track record in cell therapy release assays.

Responsibilities

• Lead and mentor the QC Operations team, ensuring compliance with GMP.
• Oversee execution of release assays ensuring timely and accurate data reporting.
• Ensure all QC activities comply with regulatory requirements.

Skills

Flow Cytometry

PCR

Microbiology

Rapid Sterility Testing

Bioassays

Lean Lab Management

Education

Bachelor’s, Master’s, or Ph.D. in a scientific discipline

Tools

Digital QC systems (e.g., LIMS, ELN)

Job description

Get AI-powered advice on this job and more exclusive features.

Made Scientific is a CDMO specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations and quality professionals work with our clients to translate groundbreaking treatments into the clinic. The novel therapeutics we focus on require constant innovation and creative thinking for clinical translation and subsequent GMP Operations to be successful. The state-of-the-art Made Scientific facility in Princeton, NJ, houses both process development labs and cleanroom spaces to support clinical manufacturing. This role will primarily be based in Princeton, with periodic travel to our Newark, NJ facility.

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 lead 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 while overseeing both the Princeton and Newark sites.

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.
• Experience in cell therapy-release assays, in CAR-T, NK Cell, IPSC, TILs modalities
• Ability to innovate and adapt best practices to a fast-paced, dynamic organization.
• Background in early- to late-phase clinical manufacturing environments.
• Strategic mindset with the ability to drive change and scale QC operations in a growing CDMO.

Required Degree

• B.S or M.S

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/ISO8 facility, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Made Scientific by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Director of Quality Control” roles.

Cranbury, NJ $150,000.00-$180,000.00 1 week ago

Director, Head of QC Operations, US site

Hopewell, NJ $156,600.00-$216,600.00 1 week ago

New Jersey, United States $150,000.00-$190,000.00 3 weeks ago

Director of Quality Assurance - Aseptic CDMO

Associate Director of Quality - Process Analytics

Director of Patient Safety and Quality, Inpatient

Perth Amboy, NJ $80,000.00-$90,000.00 2 weeks ago

Associate Director, External Data Quality Manager

Plainsboro, NJ $157,120.00-$235,680.00 5 days ago

Princeton, NJ $175,000.00-$225,000.00 2 weeks ago

Assistant Director of Janitorial Services

Edison, NJ $37,500.00-$61,607.00 2 weeks ago

Manager, QA Manufacturing Compliance, Hopewell Site

Hopewell, NJ $104,600.00-$144,600.00 1 week ago

Bridgewater, NJ $111,000.00-$156,133.00 2 weeks ago

New Brunswick, NJ $85,000.00-$124,000.00 2 months ago

Associate Director Quality Assurance Compliance, Hopewell NJ Site

Hopewell, NJ $137,200.00-$187,200.00 1 week ago

Associate Director, Quality Risk Specialist

Associate Director, Quality Risk Specialist

Business Control Manager (Corporate Functions)

Yardley, PA $95,599.00-$152,003.00 1 month ago

Cardiovascular Technologist- Per Diem Days- St Mary Medical Center

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.