Manufacturing Support Associate

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.

-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

The Manufacturing Support Associate sustains GMP readiness of Made Scientific clean rooms by executing routine and ad-hoc facility sanitization, performing viable and non-viable environmental monitoring, and supporting material/equipment/product flow throughout the facility. The role is highly detail-oriented, documentation-driven, and integral to contamination control and patient safety.

Cleanroom Cleaning & Sanitization (50% of time)

• Perform routine scheduled and ad hoc cleaning of classified clean rooms in accordance with SOPs, cGMP requirements, and regulatory expectations
• Accurately complete cleaning logs and documentation to ensure GDP compliance
• Support inspection readiness by maintaining cleanroom standards and addressing deviations promptly

Environmental Monitoring (25% of time)

• Conduct viable and non-viable environmental monitoring (e.g., settle plates, contact plates, active air sampling, and particle counts) across classified areas
• Document EM results in accordance with SOPs, ensuring accurate data collection and traceability
• Coordinate with Quality Control for submission, tracking, and follow-up of EM samples

Production Support (25% of time)

• Safely transfer raw materials, consumables, drug product, and equipment throughout the facility including classified locations
• Support material staging and preparation to enable timely manufacturing operations
• Assist production staff with ancillary support tasks as needed, such as cryopreservation transfer tasks

Compliance & Continuous Improvement

• Adhere strictly to GMP, GDP, and safety requirements during all activities
• Comply with all local policies and SOPs governing tasks performed
• Maintain training status including aseptic gowning qualification and requalification
• Identify and escalate any deviations or anomalies observed during cleaning, EM, or material handling
• Participate in training, audits, and continuous improvement initiatives such as 5S/Kaizen to sustain a culture of quality and compliance

• Associate’s degree with 1–3 years of experience in a GMP-regulated pharmaceutical, biotech, or CDMO environment
• Knowledge of aseptic technique, contamination control principles, and cleanroom operations
• Familiarity with environmental monitoring methods and good documentation standards
• Strong attention to detail with proven ability to follow SOPs and GDP requirements
• Strong teamwork and communication skills with flexibility to support cross-functional needs

• Bachelor’s degree in a science-based discipline (e.g., biology, chemistry, biotechnology)
• Prior experience with cleanroom sanitization, environmental monitoring execution, and/or materials handling is strongly preferred

• Ability to sit or stand for extended periods and perform repetitive tasks in a cleanroom environment
• Capable of lifting up to 25 lbs and working in cleanroom gowning and PPE for prolonged periods
• Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other federal, state, and local standards, including meeting productivity standards
• Ability to maintain regular, punctual attendance consistent with ADA, FMLA, and other federal, state, and local standards
• Must be willing to handle cell-based products, chemicals, or hazardous materials

• Shiftwork required, including off-shift hours, weekends, and holidays as needed to meet production demands
• Primary location:
  Princeton, NJ facility, with travel to the Newark, NJ facility up to 50% during peak periods of activity based on business needs