Head of Manufacturing Science and Technology
vor 1 Woche
A day in the Life:
- Leads the Manufacturing Science and Technology department and is responsible for processrelated activities enabling Drug Substance manufacturing of Biologics.
- Is responsible for facility fit assessment, tech transfer activities, coordination of process startup 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 startup, 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 nonconformances.
- 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, atscale 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 crossdisciplinary project teams
- Good GMP knowledge and Customercentric 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)
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