USP Manufacturing Associate

About the Role
Global Life Science Hub is recruiting on behalf of an innovative biopharmaceutical organization seeking a skilled Upstream Manufacturing Associate. This is an excellent opportunity for a motivated professional to join a forward-thinking team, contributing to the production of mammalian-based biosimilars in a cGMP environment.

In this role, you’ll manage mammalian cell culture processes, working on bioreactor operations from 50L to 1000L volumes for engineering and clinical batches. You’ll bring technical expertise, teamwork, and an eye for detail to ensure production standards are met efficiently.

Key Responsibilities

• Execute upstream manufacturing processes with a collaborative 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.
• 2+ 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.

Skills and Competencies

• Strong interpersonal and teamwork skills, with the ability to work independently.
• Excellent communication skills, both written and verbal.
• Proficiency in Word, Excel, and basic spreadsheet applications.
• Thorough understanding of GMP documentation, auditing, and validation processes.

Why Join?
This role offers the chance to work in a dynamic, cutting-edge environment based in New Jersey, where you’ll contribute to the development of vital biopharmaceutical products. It’s a fantastic opportunity for career growth and to make a real impact in the industry.