Manufacturing Support Associate

Manufacturing Support Associate

The Manufacturing Support Associate plays a crucial role in maintaining the GMP readiness of cleanrooms by performing routine and ad-hoc facility sanitization, conducting viable and non-viable environmental monitoring, and supporting the flow of materials, equipment, and products throughout the facility. This role is detail-oriented and documentation-driven, integral to ensuring contamination control and patient safety.

Responsibilities

• 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.
• Conduct viable and non-viable environmental monitoring across classified areas.
• Document environmental monitoring results in accordance with SOPs, ensuring accurate data collection and traceability.
• Coordinate with Quality Control for submission, tracking, and follow-up of environmental monitoring samples.
• Safely transfer raw materials, consumables, drug products, 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.
• 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, environmental monitoring, or material handling.
• Participate in training, audits, and continuous improvement initiatives such as 5S/Kaizen to sustain a culture of quality and compliance.

Essential Skills

• Associate's degree in the sciences.
• 1–3 years of experience in a GMP-regulated pharmaceutical, biotech, or CDMO environment.
• Experience with environmental monitoring and aseptic techniques.
• Knowledge of 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.

Work Environment

This position requires shift work, including off-shift hours, weekends, and holidays as needed to meet production demands. The primary location is the Princeton, NJ facility, with travel to the Newark, NJ facility up to 50% during peak periods of activity based on business needs. The work involves sitting or standing for extended periods and performing repetitive tasks in a cleanroom environment, requiring the ability to lift up to 25 lbs and work in cleanroom gowning and PPE for prolonged periods. It involves handling cell-based products, chemicals, or hazardous materials. The organization operates as a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in autologous and allogeneic cell therapy products.

Pay and Benefits

The pay range for this position is $28.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Princeton, NJ.

Application Deadline

This position is anticipated to close on Oct 22, 2025.