Materials Scientist, Cell & Gene Therapy (Limited to 2 years) | Materials Scientist (f/m/d) Cell &Gene Therapy
Roche Diagnostics GmbH
Job Summary
Join Roche's Material Science and Strategy team within Pharma Cell & Gene Therapy (PTC) as a Material Qualification Coordinator, playing a pivotal role in shaping the future of Cell and Gene Therapy (CGT). This position involves leading cross-functional teams to execute material strategies, developing and implementing material qualification and onboarding strategies, and coordinating key activities like risk assessments and change management. The role requires establishing lean methodologies and standardized processes for GMP material qualification, supporting the introduction of new raw materials, and creating qualification documents. Ideal candidates will have a strong background in biopharmaceuticals, cGMP regulations, and a deep understanding of materials and their regulatory implications in CGT. This is a unique opportunity to contribute directly to innovative medicines in a dynamic, international environment.
Required Skills
Education
Bachelor's degree in Life Sciences, Biotechnology or Engineering; Master's degree or PhD preferred
Experience
- 8-11 years of professional experience in the biopharmaceutical industry and a cGMP environment with a Bachelor's degree
- 6-9 years of professional experience in the biopharmaceutical industry and a cGMP environment with a Master's degree
- 3-6 years of professional experience in the biopharmaceutical industry and a cGMP environment with a PhD
- Expert knowledge of cGMP regulations and quality assurance principles, ideally within Cell and Gene Therapy (ATMPs)
- Deep understanding of materials, associated risks, and regulatory implications within CGT
- Experience as a facilitator in cross-functional matrix teams
Languages
Additional
- Willingness to travel internationally (up to 20%); This position is limited to 2 years.
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