Aseptic Manufacturing Operator

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 Aseptic Manufacturing Operator , 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.