Project Manager

For our client, a renowned pharmaceutical company in Zurich, we are currently looking for a Project Manager

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 company's Global Process Science Lead in the Technology Transfer project to drive decision making at local/site level from a Global perspective to establish site readiness for Engineering and PPQ runs.
• Represent knowledge from Sending Unit (Process and Manufacturing).

Responsibilities:

Job Function and Description

• Connect with the company's 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 company's 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

Education and Experience Requirements

• Min. MSc in Biotechnology or comparable education
• Well established DS (Cell Culture and Purification) and DP (Filling, Lyo) expertise

Key Skills, Abilities, and Competencies

• 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

The deadline for the submission of the applications is on Wednesday, January 8th at 12.00.