Jobdescription
For our client, an international company based inNeuchâtel, we are looking for a Project Delegate - Global ProcessScience Lead DS & DP
GeneralInformation:
* Workplace:Neuchâtel or Zurich
* Contract: Temporary
* Start date :January 2025
* End date:November 2027
* Workload:100%
Tasks andresponsibilities:
* Projectspecific Global Process Science Lead representing the Process Ownerfor a Biologics Large Molecule in the hematology area in a B2Bproject in SouthAmerica
* Represent the GlobalProcess Science Lead in the Technology Transfer project to drivedecision making at local/site level from a Global perspective toestablish site readiness for Engineering and PPQruns
* Represent knowledgefrom Sending Unit (Process andManufacturing)
* Connect withSite Project team and External Business Partner Team (which isowning the receiving Unit) to explain criticality of process steps,share Manufacturing know how and serve as a Senior Technologyconsultant
* Firm inunderstanding of best practices and regulation to perform ProcessPerformance Qualification for a commercialized product in SouthAmerica
* Drive Technologytransfer (TT) document creation as permethodology
* Establish andmaintain effective communication channels with stakeholders,providing regular updates on process transfer risks, status, andmitigationrecommendations.
* Developsgap assessments and mitigation recommendations together withProcess Science Leads and subject matter experts, seeks stakeholderand leadershipendorsement
* Review documentsand provide risk assessments and rationales to support thedifferent phases of a TT, including PQ,PPQ and manufacturingactivities
Yourprofile:
* Min. MSc inBiotechnology or comparableeducation
* Fluently Englishskills
* Fluently French orPortuguese skills would bebeneficial
* Well establishedDS (Cell Culture and Purification) and DP (Filling, Lyo)expertise
* Has/showsseniority/maturity on technical level and when interacting withteams and SMEs
* Can workautonomously
* Consultancy/contractorexperience
* Knows how to workin a team/matrix environment (work consensual and data driven,avoids directivecommunication)
* Can navigatein complex environments (Internal Global/Local model &(business)partnerships)
* PPQ/TTexperience
* Open to Travelinternationally