Description
Freelance/temporary employment for a project
Neuchatel
Start date: asap
Reference number: 780194/1
### Responsibilities ###
* 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
### Profile ###
* 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
### Benefits ###
* A very renowned company
* Good infrastructure
* Continuous support during the assignment