Senior Biopharmaceutical Manufacturing Expert – Freelance/B2B
Biologics Manufacturing | mAbs | USP/DSP | Single-Use | GMP
We are supporting a client with the set-up and start-up of a new GMP biopharmaceutical manufacturing area and are looking for an experienced Biopharmaceutical Manufacturing Expert to join the project on a freelance/B2B basis.
The Project
You will provide hands-on technical expertise during the preparation and start-up of a new biologics manufacturing environment.
The scope may include:
- Supporting the set-up, commissioning and operational readiness of new GMP manufacturing areas
- Providing technical expertise across biologics/mAb manufacturing processes
- Supporting upstream and/or downstream processing activities
- Working with single-use manufacturing equipment and technologies
- Supporting processes such as cell culture, filtration, TFF, UF/DF, purification and related bioprocessing activities
- Supporting equipment and process qualification/validation
- Reviewing and developing SOPs, manufacturing instructions, risk assessments and other GMP documentation
- Identifying technical risks and supporting troubleshooting and process improvements
- Supporting knowledge transfer and providing technical guidance to manufacturing/project teams
- Working closely with Manufacturing, Engineering, Quality, Validation, MSAT and other project functions
Relevant experience could include:
- Biologics or mAb manufacturing
- Mammalian/CHO cell culture
- Upstream Processing (USP)
- Downstream Processing (DSP)
- Bioprocessing / Process Engineering
- MSAT / Manufacturing Science & Technology
- Single-use systems
- TFF, UF/DF, filtration or purification
- GMP manufacturing
- Facility or manufacturing area start-up
- Commissioning, qualification or validation
- Operational readiness / technology transfer