Senior Global Process Science Lead DS & DP

m/f/d, Zürich

The role involves serving as the Global Process Science Lead for a biologics large molecule project in hematology within a business-to-business collaboration in South America. Responsibilities include acting as the primary representative of the Process Owner, ensuring effective technology transfer and decision-making aligned with the global perspective of the organization. This includes driving site readiness for engineering and PPQ (Process Performance Qualification) runs while providing expertise and insights from the Sending Unit's process and manufacturing knowledge.

Ihre Aufgaben:

Connect with the client'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 perform PPQ for a commercialized product in South America
Drive TT document creation as per client'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

Ihr Profil:

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
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

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