About the job

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

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities