Senior Scientist Tech transfer (m/f/d)

Ihre Aufgaben:
• Responsible for supporting commercial manufacturing performance at the external manufacturing site
• Represents MS&T external manufacturing team to provide technical support to the biological drug substance tech transfer process including deviation resolution, change management, delivery of yield targets and process optimization
• Maintains strong working relationships with external and internal partner
• Interface with internal functions such as MS&T, Quality, and Supply Chain
• Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving
• Tracks progress of routine manufacturing against schedule, provides routine updates and proactively identifies operational risks and remediation
• Ensures timely escalation of potential technical, compliance or safety issues to the MS&T team and partners with internal MS&T resources to remediate
• Ensures effective communication between technical transfer internal and external team
• Support technology transfer activities as a primary duties
• Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements

Ihre Qualifikationen:
• Minimum B.S. in related sciences and solid GMP regulated industry experience or Master’s degree in related sciences and solid GMP regulated industry experience
• Science or engineering degree in chemical engineering, mechanical engineering, biotechnology, biochemical or related discipline
• Experience in drug substance manufacturing essential to the role
• A strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering
• Demonstrated ability to work independently and prioritize activitie
• A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential
• Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions
• Demonstrated ability in technical writing, computer-based knowledge and communication skills

Ihre Vorteile:
• A very renowned company
• Good infrastructure
• Continuous support during the assignment

Projektdauer: 6 MM


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