Manufacturing Associate , Downstream Processing

Manufacturing Associate I, Downstream Processing

Pennington, NJ

The Manufacturing Associate will be responsible for the day‑to‑day operations of downstream processing in a clean room environment. This role includes buffer and media preparation, chromatography, tangential flow filtration (TFF), viral filtration, and aseptic processing.

• Buffer and Media Preparation:
  Prepare and maintain buffers and media required for downstream processes. Ensure accurate formulation and timely availability of all solutions. Maintain detailed records of preparation and usage.
• Chromatography:
  Operate and maintain chromatography systems for protein purification. Monitor process parameters and ensure consistent product quality. Troubleshoot and resolve any issues that arise during chromatography runs.
• Tangential Flow Filtration (TFF):
  Perform TFF operations for concentration and diafiltration of biopharmaceutical products. Optimize TFF parameters to achieve desired product specifications. Document all TFF activities and results.
• Viral Filtration:
  Conduct viral filtration to ensure the safety and purity of biopharmaceutical products. Validate and monitor viral filtration processes. Maintain compliance with regulatory standards for viral safety.
• Aseptic Processing:
  Perform aseptic processing in a clean room environment. Adhere to strict aseptic techniques to prevent contamination. Ensure compliance with Good Manufacturing Practices (GMP).
• Clean Room Operations:
  Maintain a clean and organized work environment. Follow all clean room protocols and procedures. Participate in regular clean room maintenance and cleaning activities.
• Documentation and Compliance:
  Maintain accurate and detailed records of all manufacturing activities. Ensure compliance with GMP and regulatory requirements. Participate in audits and inspections as needed.

• Education and Experience:
  
  Bachelor's degree in biotechnology, Biochemistry, Chemical Engineering, or a related field with 0+ years of relevant experience. (H.S diploma with 4+ years of experience will be considered).
• Skills:
  
  Ability to follow instructions and procedures. Experience with buffer and media preparation, chromatography, TFF, viral filtration, and aseptic processing a plus. Excellent problem‑solving and analytical skills. Effective communication, and teamwork abilities. Strong knowledge and experience working in a biopharmaceutical cGMP‑regulated environment. This position requires the ability to stand for extended periods, bend, and lift objects weighing up to 50 pounds. Candidates must be physically capable of performing these tasks safely and effectively.

$25.50/hr to 32.00/hr

• Life and AD&D Insurance
• Disability Insurance
• 401k Retirement Plan