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 in understanding of best practices and regulation to oerform 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
• 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

Your experience/knowledge:

• 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
• 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
• Fluently English skills
• Fluently French or Portuguese skills would be beneficial
• Open to Travel to Brazil
• Your soft skills:
• Strong interpersonal, communication, negotiation and problem-solving skills
• Strong attention to details, ability to review & managing 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

Duration:

• Take the next step and send us your resume along with a daytime phone number where we can reach you., , , 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
• 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
• 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