Senior Scientist Tech transfer (m/f/d)
- 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
- 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
- A very renowned company
- Good infrastructure
- Continuous support during the assignment
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