Manufacturing Associate

Manufacturing Associate Level 1 or 2

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.