Pharma Universe

Manufacturing Scientist - Upstream

Morristown, NJ, US

3 days ago
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Summary

About The Role

We're building a high-impact Drug Substance Manufacturing team at a brand-new, state-of-the-art site in New Jersey - and on the lookout for 5 new Manufacturing Scientists who thrive in fast-paced, science-driven environments.

You'll be part of a mission-critical team scaling up biologics manufacturing processes from pilot scale to 2000L single-use bioreactors in preparation for commercial GMP production. This is a unique opportunity to be on the front lines of large-scale biologics manufacturing, supporting first-in-plant execution of clinical and commercial batches in a hands-on, GMP shop floor environment.

Responsibilities:

  • Perform cell culture operations including seed expansion, cell inoculation, cell growth monitoring, and harvest in single-use bioreactors (SUBs) up to 2000L
  • Prepare and operate equipment for media and buffer preparation, seed train, and clarification processes (e.g., depth filtration)
  • Accurately execute GMP batch records, logbooks, and documentation in real time
  • Ensure aseptic technique and contamination control in cleanroom environments
  • Support facility and equipment readiness, including area/equipment prep, cleaning, and turnover
  • Follow cGMP, EHS, and SOP guidelines with precision and consistency
  • Participate in shift-based operations (including potential nights/weekends on rotation)


Qualifications

  • Associate's or Bachelor's degree in Biotechnology, Biochemistry, or related field
  • 2-6+ years of experience in upstream biologics manufacturing (Associate II/III level)
  • Hands-on experience with bioreactor operations, seed train, and clarification required
  • Comfortable working in a GMP cleanroom with strict gowning and hygiene procedures
  • Reliable, detail-oriented, and team-focused with excellent documentation habits

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