Upstream Manufacturing Associate
Job in
Newark, Essex County, New Jersey, 07175, USA
Listed on 2026-02-12
Listing for:
Global Life Science Hub
Full Time
position Listed on 2026-02-12
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer, Operations Engineer
Job Description & How to Apply Below
This role is focused on the execution of mammalian cell culture operations to support the manufacture of recombinant proteins for a portfolio of mammalian-derived biosimilars. The successful candidate will be involved in running engineering and clinical-scale batches within a cGMP manufacturing environment, working across bioreactor volumes ranging from 50L up to 2000L. A strong technical understanding of upstream processing, documentation, and GMP compliance is essential.
Key Responsibilities- Execute mammalian cell culture activities including seed expansion, inoculation, culture monitoring, and harvest using single-use bioreactors up to 2000L
- Prepare and operate equipment for media and buffer preparation, seed train activities, and clarification steps such as depth filtration
- Complete GMP batch records, logbooks, and associated documentation accurately and in real time
- Maintain strict aseptic practices and contamination control within classified cleanroom areas
- Support equipment and facility readiness, including cleaning, setup, and area turnover
- Adhere to cGMP, SOP, and EHS requirements at all times
- Participate in a shift-based manufacturing schedule, which may include nights or weekends on rotation
- Associate’s or Bachelor’s degree in Biotechnology, Biochemistry, or a related scientific discipline
- Typically 2–6+ years of experience in upstream biologics manufacturing (Associate II / III level or equivalent)
- Practical experience with bioreactors, seed train operations, and clarification processes
- Comfortable working in GMP cleanroom environments with full gowning requirements
- Highly reliable, detail-focused, and collaborative, with strong documentation discipline
- Ability to work effectively both independently and within a team environment
- Clear verbal and written communication skills with strong organisational ability
- Proficient in basic computer applications, including Word and Excel
- Solid understanding of GMP manufacturing documentation, batch record review, and audit readiness
Position Requirements
10+ Years
work experience
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