Manufacturing Support Associate - Made Scientific : Job Details

About Made Scientific

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.

Position Summary

The 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 Responsibilities

Cleanroom 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 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

Required 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 needs

Preferred 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 preferred

Physical 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 materials

Work 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