Manufacturing Associate

Manufacturing Associate at Made Scientific Manufacturing Associate at Made Scientific in Kingston, New Jersey Posted in about 14 hours ago.

Type:

full-time

Job Description:

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. 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 Associate will support Cell Therapy Operations at our GMP-compliant facility, playing a critical role in the production of cutting-edge cell therapies. This position is ideal for a detail-oriented professional with strong aseptic technique and a proven ability to quickly master complex processes in a cleanroom environment. The successful candidate will demonstrate a deep commitment to current Good Manufacturing Practices (cGMP) and thrive in a collaborative, quality-driven setting. This role requires precision, adaptability, and a strong quality mindset to ensure the consistent delivery of high-standard therapeutic products. Key Responsibilities

• Perform aseptic manufacturing operations within a classified cleanroom environment, ensuring compliance with all cGMP and safety standards.
• Execute complex procedures for cell therapy manufacturing and sterile product operations-including cell culture, formulation, and cryopreservation-while maintaining strict adherence to written procedures, batch records, and cGMP regulations.
• Operate and maintain specialized manufacturing equipment, ensuring proper calibration and functionality.
• Monitor and document all production processes with precision, ensuring traceability and compliance with regulatory standards.
• Identify and escalate deviations or non-conformances; participate in root cause analyses and implement corrective actions.
• Collaborate cross-functionally with Quality, Process Development, and Engineering teams to support continuous improvement initiatives.
• Perform routine cleanroom maintenance, including environmental monitoring, cleaning, and sterilization activities.
• Maintain an organized, compliant workspace by following 5S principles and minimizing contamination risks.
• Participate in training sessions to stay current with manufacturing techniques, quality standards, and safety protocols.
• Support process development activities during technology transfer.
• Aseptically gown and work in ISO 8, 7, and 5 cleanroom environments and stand for extended periods.
• Assist in creating and reviewing Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).
• Review MBRs daily to ensure documentation is accurate and complete.
• Participate in audits, inspections, qualifications, and validation activities.
• Handle chemicals such as corrosives, solvents, and biohazardous materials safely.
• Perform other duties as assigned. Required Qualifications
• Bachelor's degree in Biology, Biotechnology, or a related field preferred; equivalent experience will be considered.
• 1-3 years of experience in GMP manufacturing, preferably in cell therapy, biologics, or pharmaceutical CDMO operations.
• Strong knowledge of aseptic techniques and cleanroom protocols.
• Proficiency in basic mathematical concepts, including scientific notation.
• Proven ability to learn and master complex processes quickly.
• Exceptional attention to detail with a strong commitment to quality standards.
• Excellent collaboration, communication, and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment with shifting priorities. Preferred Qualifications
• Experience in aseptic cell culture processing in ISO 5 biosafety cabinets, using universal precautions for handling human-derived materials.
• Familiarity with cell therapy automation technologies, closed system culture vessels, cell washers, and cell separation technologies for autologous or allogeneic product manipulation.
• Experience handling, propagating, isolating, activating, and cryopreserving human primary cells, including T cells.
• Proficiency in basic computer applications (e.g., Microsoft Office, electronic batch record systems). Physical Requirements
• Ability to stand for extended periods and perform repetitive tasks in a cleanroom environment.
• Must be able to lift up to 25 lbs. and work in full cleanroom gowning and PPE for extended durations.
• Ability to perform essential job functions safely and successfully in compliance with ADA, FMLA, and other applicable standards, including meeting productivity expectations.
• Willingness to bend, stoop, carry, reach, climb, or stand on elevated benches or step stools.
• Must be comfortable working with cell-based products, chemicals, and hazardous materials. Work Schedule
• Must be available for shift work, including off-shift hours, weekends, and holidays, as needed to meet production demands.

Flexibility to accommodate changing production schedules is required.