Project Lead Cmc

vor 1 Woche

Munich, Deutschland Progressive Recruitment NL Vollzeit

As part of the CMC organization, the Project Lead CMC Biopharma (w/m/d) will play a central role in coordinating analytical method transfers across the companys global supplier and partner network, continuously drive life cycle management activities and contribute to the strategic project planning of QC-related activities.

**Responsibilities**:

- Coordinate and supervise analytical method transfers to CMOs and partners for the establishment of global manufacturing networks
- Develop and supervise the life cycle management for analytical methods (implementation, validation, trending, continuous improvement) in a global manufacturing network
- Provide QC input for process validation and compilation of Module 3 content for late stage development projects approaching global submissions
- Contribute to the setup and maintenance of processes for analytical data handling in the context of sponsor oversight for our manufacturing networks
- Contribute to strategic project planning for in-house and outsourced QC related testing activities
- Represent QC in internal and external cross-disciplinary teams as responsible expert for method life cycle and analytical transfers

Your experience:

- Degree in Life Sciences, Pharmacy or Bioengineering
- Ideally at least 8 years of experience in biotechnology or pharmaceutical industry with a minimum of 3 years of pertinent experience in the field of quality control
- Solid understanding of GMP principles and regulatory requirements
- Experience in instrumental analytics in the context of biopharmaceutical development as well as in QC life cycle management
- Experience in the compilation of QC related content in submissions for late stage development projects
- Clear commitment to work in the highly regulated area of pharmaceutical manufacturing and to represent QC in cross-disciplinary working groups
- Highly motivated and open-minded team player with well-developed interpersonal and intercultural abilities
- Excellent communication skills, both in English and German

**Interessiert an dieser Möglichkeit**?**
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**München, Project Manager, Pharma, Biotechnology, Projectmanager, Biologics, Healthcare,

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