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.
* Share knowledge from Sending Unit (Process and Manufacturing).
* Connect with TAK Site Project team and External Business Partner Team (owning the receiving Unit) to explain critical process steps, share manufacturing know-how, and serve as a Senior Technology consultant.
* Ensure 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 strategies.
* Develop gap assessments and mitigation recommendations with Process Science Leads and SMEs, seeking stakeholder and leadership approval.
* Review documents and provide risk assessments and rationales to support different phases of 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.
* Seniority and maturity in technical interactions and team collaboration.
* Consultancy or contractor experience.
* Ability to work in a team/matrix environment, emphasizing data-driven and consensual decision-making.
* Experience navigating complex environments with global/local models and partnerships.
* PPQ / TT experience.
* Fluent English skills; French or Portuguese skills are a plus.
* Willingness to travel to Brazil.
Your soft skills:
* Strong interpersonal, communication, negotiation, and problem-solving skills.
* Attention to detail, with the ability to review and manage documentation.
* Highly punctual, systematic, organized, and concise in communication.
* Ability to work effectively in multi-functional and multicultural teams.
* Unquestionable integrity and professionalism.
* Customer and patient-oriented mindset.
Location: Zurich, Switzerland
Sector: Pharmaceutical
Start: ASAP
Duration: 24 months+
Ref. Nr.: BH
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens, or current Swiss work-permit holders.
Ukrainian refugees are warmly welcomed, and we will support you throughout the process.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. No gender or photo is required in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. We are happy to explore solutions for applicants with disabilities.
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