Manufacturing Consultant

Discover International; Bayern; Vor Ort; EUR 110.000 - 170.000; Vollzeit

Zusammenfassung

Discover International is seeking a Senior Biopharmaceutical Manufacturing Expert to join a freelance/B2B project focused on the set-up and start-up of a new GMP biopharmaceutical manufacturing area. You will provide hands-on technical expertise across biologics/mAb processes, including USP/DSP, single-use systems, and associated qualification activities.

The role involves supporting commissioning, operational readiness, and knowledge transfer to manufacturing teams, MSAT, QA, and validation

Qualifikationen

• Experience in biologics or mAb manufacturing.
• Mammalian/CHO cell culture experience.
• Upstream and/or downstream processing knowledge.
• GMP manufacturing experience and documentation.
• Qualification/validation support or lead.
• SOPs, manufacturing instructions and risk assessments understanding.

Aufgaben

• Provide hands-on technical expertise during setup and start-up of a new biologics manufacturing environment.
• Support commissioning and operational readiness of GMP manufacturing areas.
• Deliver technical input across biologics/mAb manufacturing processes (USP/DSP).
• Work with single-use manufacturing equipment and technologies.
• Support process qualification/validation and risk assessments.
• Contribute to knowledge transfer and cross-functional guidance across teams.

Kenntnisse

Biopharmaceutical manufacturing

Process engineering

Technical troubleshooting

Knowledge transfer

Ausbildung

Bachelor’s degree in a relevant field

Tools

Single-use systems

Jobbeschreibung

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