Manufacturing Consultant

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