Manufacturing Associate

We at Global Life Science Hub are recruiting on behalf of a pioneering biotech company that is scaling rapidly after securing FDA approvals and expanding their commercial capabilities. This role is crucial to the production of high-quality biotechnology products for clinical and commercial human use.

As an Manufacturing Associate, you will employ aseptic techniques within controlled, classified environments, adhering strictly to current Good Manufacturing Practices (cGMP) and internal SOPs. This role requires attention to detail and a commitment to maintaining high standards in compliance and safety.

Key Responsibilities:

• Perform daily operations, including:
• Weighing and dispensing materials
• Using filtration systems
• Inoculating mammalian or cytokine cells
• Overseeing fermentation and harvest processes
• Operating chromatography columns and TFF systems
• Conduct in-process testing, such as pH, conductivity, and spectrophotometry
• Prepare media and buffer solutions
• Accurately complete Batch Records and other cGMP documentation
• Maintain the cleanroom and ensure conditions meet GMP standards
• Report nonconformances or issues to the Supervisor
• Support technology transfer from Process Development to Manufacturing
• Comply with all safety and company policies

Qualifications:

• Education: Associate degree or higher in Biology, Chemistry, Biotechnology, or a related field preferred
• Experience: 2-4 years in the biologics industry, ideally in a cGMP environment

Skills:

• Technical: Familiarity with aseptic filtration, fermentation, inoculation, chromatography, and TFF systems
• Communication: Basic proficiency in English for understanding technical documents and procedures
• Problem Solving: Ability to troubleshoot equipment and processes and work independently or as part of a team
• Computer Skills: Experience with word processing, spreadsheets, and data management

Work Environment & Physical Demands:

This position requires flexibility in hours and the ability to work under pressure. Some travel may be required.