Senior Expert Biopharmaceutical Manufacturing

Senior Expert Biopharmaceutical Manufacturing (m/f/d)

Onsite: Up to 50%

1 Year Contract

Start Date: January 2027

Project Objective

For the establishment of a new biopharmaceutical production area for the production of highly potent antibody-drug conjugates (ADC), we are looking for an experienced senior expert to support during the project and development phase.

The focus is on technical support in setting up the production area, implementing GMP-compliant processes and preparing for the operational start of production in close cooperation with the project team.

Tasks

• Expert advice on the construction of a new biopharmaceutical production area as part of a new construction project
• Project-related coordination with Manufacturing Support to ensure operational milestones and project deadlines
• Development and implementation of GMP-compliant processes, standards and organizational procedures
• Creation and review of GMP-relevant documentation such as SOPs, work instructions, manufacturing instructions, risk analyses, URSes and documents for cleaning validation
• Expert advice on qualification, validation, and operational readiness activities
• Project-related participation in the development of GMP- and EHS-compliant concepts for the safe operation of the production area
• Technical advice to the project teams during the set-up phase as well as knowledge transfer on processes, plants and GMP requirements

Requirements

• Degree in biotechnology, biochemistry, pharmacy, process engineering or comparable qualification desirable
• At least 5 years, ideally 10 years of experience in biopharmaceutical manufacturing in a GMP-regulated environment
• In-depth practical experience in the field of mAB manufacturing
• Experience with TFF, filtration, UF/DF or comparable biotechnological manufacturing processes
• Hands-on experience with single-use technologies and disposable production systems
• Experience in the construction, commissioning or start-up of pharmaceutical or biotechnological production plants
• Very good knowledge of GMP documentation, risk analyses, qualification and validation
• Strong hands-on mentality and high implementation skills
• Structured, independent and solution-oriented way of working
• Ability to lead teams professionally and impart knowledge in a practical way
• Experience in interdisciplinary project teams
• Very good knowledge of German and English