What are the responsibilities and job description for the Manufacturing Associate (Upstream OR Downstream) position at Global Life Science Hub?
We are partnering with a growing biopharmaceutical company seeking Manufacturing Associates to support GMP manufacturing operations. This role is open to candidates with upstream (cell culture/bioreactors) or downstream (purification) experience and will play a key role in executing engineering and clinical-scale batches in a cGMP environment.
Key Responsibilities
Upstream Focus (as applicable):
- Execute mammalian cell culture and bioreactor operations at 50L–1000L scale.
- Support engineering and clinical batch execution in a cGMP environment.
- Monitor and adjust process parameters to ensure optimal performance.
- Review executed batch records and associated GMP documentation.
Downstream Focus (as applicable):
- Execute downstream purification processes including chromatography, TFF, and column packing.
- Operate AKTA systems or similar purification skids.
- Perform process troubleshooting, data analysis, and scale-up support.
- Support engineering and clinical batch execution in a cGMP environment.
Shared Responsibilities:
- Initiate, execute, and review GMP batch records and protocols.
- Support deviations, investigations, and corrective actions as required.
- Collaborate cross-functionally with Quality, Engineering, and other manufacturing teams.
- Ensure adherence to GMP, safety, and environmental policies.
- Contribute to continuous improvement of manufacturing processes and documentation.
Requirements
- Bachelor’s or Master’s degree in Chemical, Biological, Biochemical Sciences, or related discipline.
- Proven experience in a GMP-regulated biopharmaceutical manufacturing environment.
- Hands-on experience in either upstream or downstream manufacturing operations.
- Strong understanding of GMP documentation, batch records, and investigations.
- Experience with single-use manufacturing systems and consumables preferred.
- Strong communication skills and high attention to detail.
- Ability to work independently and within cross-functional teams.