Manufacturing Support Associate

About Made ScientificMade 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.Position SummaryThe Manufacturing Support Associate sustains GMP readiness of Made Scientific cleanrooms 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.Key ResponsibilitiesCleanroom Cleaning & Sanitization (50% of time)• Perform routine scheduled and ad hoc cleaning of classified cleanrooms 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 promptlyEnvironmental 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 samplesProduction 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 tasksCompliance & 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 complianceRequired Qualifications• 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 needsPreferred Qualifications• 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 preferredPhysical Requirements• 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 materialsWork Schedule• 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

Created: 2025-09-26