Head of Manufacturing Science and Technology

A day in the Life:

• Leads the Manufacturing Science and Technology department and is responsible for process-related activities enabling Drug Substance manufacturing of Biologics.
• Is responsible for facility fit assessment, tech transfer activities, coordination of process start-up activities including Engineering Runs, GMP/clinical, PPQ and routine commercial runs, and resulting risk mitigation activities.
• Coordinates the process and cleaning validation strategy, including risk assessments (ex. Extractables and Leachables)
• Supports manufacturing activities with data trending and continuous process verification, deviations resolution, process improvements and scientific expertise in the Drug Substance field

Responsibilities:

• Responsible for inbound technology transfer, facility and process gap assessments, process start-up, validation strategy and process risk mitigation activities, while maintaining schedule and cost objectives.
• Coordinates scientifically and/or technically based process improvements of clinical and commercial manufacturing processes, and facilitates the resolution of manufacturing non-conformances.
• Actively liaises with external customers and internal partners to facilitate execution of customer projects.
• Coordinates with global stakeholders to advance the standardization of technology platforms, validation strategies and site readiness for new commercial trends.

Education:

Minimally MSc in in biotechnology, cell biology, molecular biology, biochemistry or related field
Language: Fluency in English, German knowledge preferable
Knowledge, Skills, Abilities

• ≥8 yrs experience in process development, at-scale manufacturing, and/or product stewardship.
• Broad experience in all process areas (USP, DSP, buffer and media preparation) and ancillary processes (CIP, SIP).
• Proficiency in working with multicultural and cross-disciplinary project teams
• Good GMP knowledge and Customer-centric mindset
• Experience in leading teams
• Excellent organization, planning, problem solving and critical thinking skills
• Excellent writing, communication and presentation skills
• Energy and drive (action oriented, drive for results)