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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