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Downstream Manufacturing Associate

Pharma Universe
Piscataway, United Statesfull_timeVerifiedPosted 14 May 2025

About the role

Downstream Manufacturing Associate – Night Shift (3rd Shift: 10:00 PM – 6:00 AM)
Full-Time | Onsite – New Jersey, USA
Relocation support offered

Global Life Science Hub is recruiting on behalf of a leading global biopharmaceutical company, seeking a Downstream Manufacturing Associate to support overnight operations at their cGMP-compliant facility in New Jersey. This role is essential for executing purification and recovery processes for biosimilar manufacturing on the 3rd shift (10:00 PM – 6:00 AM), helping ensure uninterrupted 24/7 operations.

Key Responsibilities:

  • Perform downstream processing operations including chromatography (AKTA), TFF, and ultrafiltration/diafiltration at 50 L to 1000 L scale
  • Operate single-use systems and purification equipment in accordance with batch protocols and cGMP standards
  • Monitor key process parameters, conduct in-process sampling, and maintain accurate, real-time documentation
  • Work closely with cross-functional teams to support effective shift handovers and consistent production flow
  • Contribute to deviation investigations and continuous improvement efforts
  • Maintain a clean and compliant manufacturing environment in line with safety and environmental protocols
  • Assist with reviewing executed batch records and supporting documentation

Requirements:

  • Bachelor’s or Master’s degree in Biochemistry, Biology, Chemical Engineering, or related field
  • Minimum 2 years of hands-on downstream processing experience in a GMP-regulated biologics manufacturing setting
  • Proficiency in chromatography techniques (e.g., AKTA systems), filtration methods, and use of single-use technologies
  • Familiarity with aseptic techniques and cleanroom operations
  • Reliable and committed to working a consistent overnight (3rd shift) schedule
  • Strong attention to detail, with excellent documentation and communication skills
  • Able to work both independently and within a collaborative team environment

This is a great opportunity for professionals looking to grow their career within a high-performing biologics manufacturing team, while benefiting from a stable night shift structure.

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Pharma Universe

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