Senior Specialist, Quality Control

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. We are expanding our team and seeking a Senior QC Specialist to support in-process and release testing for Cell and Gene Therapy (CGT) products. The Senior QC Specialist will also contribute to stability studies, microbiology, analytical, and reagent testing, delivering high-quality, on-time results to meet manufacturing demands.

Key Responsibilities

• Perform analytical and microbiological testing of CGT (Cell and Gene Therapy) products, including Sterility and Endotoxin testing in a controlled cGMP environment.
• Serve as lead trainer and subject matter expert on analytical methods, including Flow cytometry, PCR and ELISAs, while mentoring junior staff.
• Coordinate GMP QC lab operations and inventory, ensuring compliance with company policies and applicable requirements.
• Troubleshoot and resolve issues impacting laboratory operations, test methods, equipment, or facility systems.
• Coordinate method transfers and validation of methods, utilities and equipment as applicable to ensure regulatory compliance.
• Review records for in-process monitoring, product release, and stability testing, ensuring adherence to GMP and applicable standards and procedures.
• Manage Quality System records (CAPA, Change Control, Deviations, LIR) and lead investigations of OOS results, proposing corrective actions.
• Oversee and execute environmental and method trending, QMR presentations, and Environmental Monitoring Testing in Grade A-D/ISO 5-7 areas.
• Implement, qualify, and optimize pharmacopoeia methods to enhance processes and ensure regulatory compliance.
• Create, review, and approve QC documents (SOPs, work instructions, testing methods) to ensure continuous improvement.
• Support new product and technology introductions, managing cross-functional coordination and prioritization.
• Update management on progress, roadblocks, and needs to ensure smooth project execution.
• Perform other duties as assigned to support department goals.

Required Qualifications

• PhD with 3 years of experience, Master’s Degree with 5 years of experience in the pharmaceutical industry or GMP environment, focusing on analytical methods (Flow Cytometry, PCR) or Quality Control, OR a bachelor’s degree with 7 years of relevant experience.
• In depth knowledge and hands-on experience with analytical assays, including Flow Cytometry, PCR, ELISAs.
• Extensive QC experience with a comprehensive understanding of compendial methods and regulatory guidance.
• Ability and willingness to learn and perform microbiological assays as part of the evolving needs of the team.
• Ability to thrive in a dynamic environment, manage multiple priorities, and adapt to evolving demands.
• Willingness to travel between facilities and work flexible hours, including evenings, weekends, and shift-based schedules as operational needs dictate.
• Highly organized, team-oriented, and able to work with minimal supervision while maintaining a positive attitude.
• Skilled in interacting with clients and health authorities, with strong verbal and written communication

Preferred Qualifications

• Experience with LIMS, Endotoxin, Sterility, mycoplasma, and method qualification/validation, including supporting method transfer activities.
• Familiarity with FDA, EMEA, ICH, USP, GMP guidelines, and cGMP regulations related to QC labs and cell-based product manufacturing.
• Proven ability to support lab investigations, deviations, CAPAs, and change controls.
• Knowledge of Gene/Cell therapy products, particularly in clinical production

Required Degree

• B.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