Manufacturing Associate

Work Location: Mercer County, New Jersey

Summary: Seeking a detail-oriented professional to support cell therapy production in a regulated cleanroom environment. This role requires strong aseptic technique, adaptability, and a commitment to quality standards to ensure the consistent delivery of high-standard therapeutic products.

Responsibilities: Conduct aseptic manufacturing operations in a cleanroom, adhering to cGMP and safety protocols. Execute complex cell therapy manufacturing procedures, including cell culture, formulation, and cryopreservation, while following batch records and regulatory guidelines. Operate, calibrate, and maintain specialized manufacturing equipment to ensure optimal performance. Accurately document production processes and maintain traceability in compliance with regulatory standards. Identify, escalate, and participate in investigations of deviations or non-conformances, supporting corrective actions and change controls. Collaborate with cross-functional teams to drive continuous improvement and support process development activities. Perform cleanroom maintenance, environmental monitoring, and ensure workspace organization using 5S principles. Participate in training, audits, and validation activities, and assist in the creation and review of SOPs and batch records.

Qualifications: Bachelor’s degree in Biology, Biotechnology, or related field preferred; equivalent experience considered.0–3 years of experience in GMP manufacturing, ideally in cell therapy, biologics, or pharmaceutical operations. Knowledge of aseptic technique, contamination control, and cleanroom operations. Proficiency in basic mathematical concepts, including scientific notation. Demonstrated ability to quickly learn and master complex processes. Exceptional attention to detail and strong commitment to quality standards. Excellent collaboration, communication, and interpersonal skills. Ability to work effectively in a fast-paced, dynamic environment with shifting priorities. Experience in aseptic cell culture processing in Grade A biosafety cabinets and handling human-derived materials is a plus. Familiarity with cell therapy automation, closed system culture vessels, and cell separation technologies preferred. Experience with handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells, is advantageous. Proficiency in computer applications such as Microsoft Office and electronic batch record systems preferred. Ability to stand for extended periods, lift up to 25 lbs., and work in full cleanroom gowning and PPE for long durations. Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools as needed. Comfortable working with cell-based products, chemicals, and hazardous materials. Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards.