Process Expert

The Position

Tasks & responsibilities

• In your new role you will work on the development and optimization of innovative analytical strategies for manufacturing processes of new virus modalities in pre-, early & late clinical stages.
• You will support project team members to execute time bound project goals by independent planning, coordination, and evaluation of work packages, with a focus on analytics.
• Furthermore, you will assist in regulatory submissions, facilitate interactions with health authorities, and oversee transfer activities.
• You will be accountable for efficient and successful interactions with internal and external (CROs/CDMOs/CMOs) partners.
• In a highly flexible and project-oriented manner you will deliver development work packages like analytical methods required for CMC manufacturing and you will perform hands-on drug product associated analytical activities in conjunction with your team.
• Not least you will represent analytical development in interdisciplinary and international project teams and lead a technical team in a matrix internally and with external partners. 

Requirements

• Master’s degree in Biology, Biochemistry, Biotechnology, Virology, Pharmacy or equivalent, alternatively bachelor’s degree with several years of experience in the field of analytical development or manufacturing
• Experience in analytical development of viruses or ATMPs, as well as in associated analytical methods required for process monitoring, formulation development and/or troubleshooting
• Ability and willingness to work proactively and hands-on with viruses (BSL2) in a highly entrepreneurial environment
• Pragmatic and agile working style with a high sense for quality and responsibility, as well as experience in leading work packages in a matrix internally and externally
• Team player with excellent communication skills and willingness to work in an interdisciplinary and dynamic environment where personal engagement and empowerment is highly supported
• Very good German and fluent English communication skills, both spoken and written

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