For our customer located in Zurich/Switzerland we are currently looking for a: Project Manager – Global Process Science Lead DS & DP (m/f/x)

• Location: CH-Zurich
• Branch: Pharma
• Working Model: hybrid, Open to Travel to Brazil

Tasks & Responsibilities

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

Must Haves

• Min. MSc in Biotechnology or comparable education

• Well established DS (Cell Culture and Purification) and DP (Filling, Lyo) expertise

• 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

• Open to Travel to Brazil

• Fluently English skills

• Fluently French or Portuguese skills would be beneficial

Did we catch your interest?

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.