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Upstream Manufacturing Associate

Job in Newark, Essex County, New Jersey, 07175, USA
Listing for: Global Life Science Hub
Full Time position
Listed on 2026-02-12
Job specializations:
  • Manufacturing / Production
    Pharmaceutical Manufacturing, Validation Engineer, Operations Engineer
Salary/Wage Range or Industry Benchmark: 60000 - 80000 USD Yearly USD 60000.00 80000.00 YEAR
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
Qualifications
  • 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
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Position Requirements
10+ Years work experience
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