Senior Expert Biopharmaceutical Manufacturing

Meet Life Sciences Ltd.; Pfaffenhofen an der Ilm; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Meet Life Sciences Ltd. seeks a Senior Expert Biopharmaceutical Manufacturing to support a new ADC production area.

Role focuses on GMP-compliant setup, documentation, and knowledge transfer, in close cooperation with the project team during development and transition to operations. The candidate should have 5–10 years in GMP biopharma manufacturing, strong GMP documentation, and hands-on experience with single-use systems and process development for mAB production, with German and English

Qualificações

• Degree in biotechnology, biochemistry, pharmacy, process engineering or comparable qualification desirable.
• 5+ years (ideally 10) of experience in biopharmaceutical manufacturing in GMP environment.
• In-depth experience in mAB manufacturing.
• Experience with TFF, filtration, UF/DF or similar processes.
• Hands-on experience with single-use technologies and disposable systems.
• Experience in construction, commissioning or start-up of pharma/biotech plants.
• Strong GMP documentation, risk analyses, qualification and validation knowledge.
• Leadership and knowledge transfer in project teams.

Responsabilidades

• Provide expert advice on constructing a new biopharmaceutical production area.
• Coordinate with Manufacturing Support to meet milestones and deadlines.
• Develop and implement GMP-compliant processes, standards and procedures.
• Create and review GMP documentation (SOPs, work instructions, manufacturing instructions, risk analyses, URSes, cleaning validation docs).
• Advise on qualification, validation, and readiness activities.
• Contribute to GMP- and EHS-compliant concepts for safe operation of the production area.
• Provide technical advice to project teams and transfer knowledge on processes and GMP requirements.

Conhecimentos

GMP documentation

Biopharmaceutical manufacturing

mAB manufacturing

Single-use technologies

Team leadership

Cross-functional teams

Process development

Formação académica

Biotechnology degree

Biochemistry degree

Pharmacy degree

Process engineering degree

Ferramentas

TFF

UF/DF

Descrição da oferta de emprego

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