Project Delegate - Global Process Science Lead DS & DP

Experis is the global leader in professional resourcing and project-based workforce solutions.

On beahlf of our Pharmaceutical company in Basel we are looking for a Project Delegate - Global Process Science Lead DS & DP

Start date: 13.01.2025

Duration: apporximately 3 years

Location: Zurich or Neuchatel, Switzerland

Primary Duties:

* Project specific Global Process Science Lead representing the Process Owner for a Biologics Large Molecule in the hematology area in a B2B project in South America
* Represent the TAK Global Process Science Lead in the Technology Transfer project to drive decision making at local/site level from a Global TAK perspective to establish site readiness for Engineering and PPQ runs
* Represent knowledge from Sending Unit (Process and Manufacturing)

Responsibilities:

• Connect with TAK Site Project team and External Business Partner Team (which is owning the receiving Unit) to explain criticality of process steps, share Mfg know how and serve as a Senior Technology consultant
• Firm in understanding of best practices and regulation to oerform PPQ for a commercialized product in South America
• Drive TT document creation as per TAK methodology
• Establish and maintain effective communication channels with stakeholders, providing regular updates on process transfer risks, status, and mitigation recommendations.
• Develops gap assessments and mitigation recommendations together with Process Science Leads and subject matter experts,, seeks stakeholder and leadership endorsement
• Review documents and provide risk assessments and rationales to support the different phases of a TT, including PQ,PPQ and manufacturing activities

Key Skills:

• Has/shows seniority/maturity on technical level and when interacting with teams and SMEs
• Can work autonomous
• Consultancy/contractor experience
• Knows how to work in a team/matrix environment (work consensual and data driven, avoids directive communication)
• Can navigate in complex environments (Internal Global/Local model & (business) partnerships)
• PPQ/TT experience

Other Requirements

• Open to Travel to Brazil
• Fluently English skills
• Fluently French or Portuguese skills would be beneficia

If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar elaine.kanwar(at)experis.ch or at +41 61 282 22 23