Job Description
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.
Key skill Required
- Manufacturing
- Ability To Work Under Pressure
- Attention to Detail
- Batch Records
- Biology
- Biotechnology
- Chemistry
- Chromatography
- Commitment
- Communication
- Compliance
- Data Management
- Development
- Documentation
- Fermentation
- Filtration
- Good Manufacturing Practices
- HARVEST
- Management
- Problem Solving
- Process Development
- Scaling
- Science
- Technology Transfer
- Word Processing
- Work Independently
