Senior Global Process Science Lead DS & DP (m/f/d)

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