Upstream Manufacturing Specialist

4 days ago


Piscataway, New Jersey, United States Global Life Science Hub Full time

Job Description

About the Role

Global Life Science Hub is recruiting an innovative biopharmaceutical organization seeking a skilled Upstream Manufacturing Associate. This opportunity offers a forward-thinking team to contribute to the production of mammalian-based biosimilars in a cGMP environment.

This role involves managing mammalian cell culture processes, operating bioreactors at various scales from 50L to 1000L volumes for engineering and clinical batches. The ideal candidate will bring technical expertise, teamwork, and attention to detail to ensure production standards are met efficiently.

Key Responsibilities

  • Execute upstream manufacturing processes collaboratively with a team.
  • Operate bioreactors at various scales, performing cell culture processes.
  • Ensure timely execution of engineering and clinical batches.
  • Develop and refine equipment specifications and manufacturing techniques.
  • Collect and evaluate operational data for process improvements.
  • Lead the preparation and review of batch records, protocols, and technical documents.
  • Investigate and resolve issues arising during the manufacturing process.
  • Adhere to GMP standards and support environmental health and safety policies.

Qualifications and Experience

  • Bachelor's or Master's degree in chemical, biological, or biochemical sciences.
  • 3+ years of experience in biopharmaceutical manufacturing.
  • Expertise in bioreactor operations, process development, and batch execution.
  • Knowledge of single-use manufacturing consumables (bags, tubing, manifolds, etc.).
  • Experience working in GMP and aseptic manufacturing environments.

Why Join?

This role offers the chance to work in a dynamic, cutting-edge environment based in New Jersey, contributing to the development of vital biopharmaceutical products. It's a fantastic opportunity for career growth and making a real impact in the industry.



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