QC Specialist (2nd and 3rd Shift)

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.

Position Summary

The QC Specialist II supports in-process and release testing for Cell and Gene Therapy (CGT) products. The QC Specialist II 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, Mycoplasma, Endotoxin, Flow Cytometry, Cell Count, Potency, and other testing in a controlled cGMP environment.
• Serve as lead trainer and subject matter expert on analytical methods, including Flow cytometry, PCR and ELISAs, Sterility, Environmental Monitoring, 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

• Master’s Degree with 2 years of experience in GMP environment, focusing on microbiology (Environmental Monitoring, Sterility, Endotoxin, Mycoplasma) and /o analytical methods (Flow Cytometry, PCR) or Quality Control, OR a bachelor’s degree with 3 years of relevant experience.
• In depth knowledge and hands-on experience with microbiology methods, aseptic techniques and 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 new and complex microbiological and analytical assays as part of the evolving needs of the team.
• Ability to thrive in a face-paced, dynamic environment, manage multiple priorities, and adapt to evolving demands.
• Willingness to 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

• GMP experience in Cell and Gene Therapy.
• Experience with LIMS, Endotoxin, Sterility, mycoplasma, PCR, Flow Cytometry, 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.
  
  

Physical Requirements

• Must be willing to be gown qualified and work in BSL-2 lab/CNC/ISO7/ISO8 facility.
• Must be able to lift and carry up to 25 lbs.
• Must be willing to bend, stoop, carry, reach, climb or stand on an elevated bench or step stool.
• Must be willing to sit or stand for extended periods.
• Must be willing to work with cell-based products, chemicals or hazardous materials.
• Ability to perform the essential job functions consistent safely and successfully with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards.
  
  

Work Environment

• Work is performed in a combination of manufacturing, laboratory, warehouse, mechanical, and office environments.
• May work around manufacturing equipment, mechanical systems, chemicals, and hazardous materials.
• Required to wear appropriate personal protective equipment (PPE) and follow applicable safety and GMP requirements.
• May require occasional work outside of normal business hours to support maintenance needs or facility emergencies.
• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.