Project Delegate

Project Delegate - Global Process Science Lead DS & DP vacancy for a globally operating Zurich based company in the pharmaceutical sector.

Your tasks:

• 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).
• 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 understanding of best practices and regulations to perform 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.
• Develop gap assessments and mitigation recommendations together with Process Science Leads and subject matter experts, seeking 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.

Your experience/knowledge:

• Min. MSc in Biotechnology or comparable education.
• Well established DS (Cell Culture and Purification) and DP (Filling, Lyo) expertise.
• Demonstrated seniority/maturity on technical level and when interacting with teams and SMEs.
• Consultancy/contractor experience.
• Ability to work in a team/matrix environment (work consensual and data driven, avoids directive communication).
• Ability to navigate in complex environments (Internal Global/Local model & (business) partnerships).
• PPQ/TT experience.
• Fluent in English; fluency in French or Portuguese is beneficial.
• Open to travel to Brazil.
• Strong interpersonal, communication, negotiation and problem-solving skills.
• Strong attention to detail, ability to review & manage documentation.
• Excellent attention to detail and a commitment to accuracy.
• Highly punctual, systematic, highly organized, & concise in communication.
• Ability to work successfully in multi-functional and multi-cultural teams.
• Demonstrate unquestionable integrity and professionalism.
• Customer and patient oriented mindset.

Location: Zurich, Switzerland
Sector: Pharmaceutical
Start: 01/2025
Duration: 24MM+
Ref. Nr.: BH22471

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Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed; we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.

As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.

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