Head Manufacturing Science and Technology Lengnau

Vor 2 Tagen

Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**Head Manufacturing Science and Technology Lengnau**

A day in the Life:

- Leads the Manufacturing Science team and is responsible for process related activities enabling Drug Substance manufacturing of Biologic’s.
- 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.
- Supports manufacturing activities with data trending, deviations resolution, process improvements and scientific expertise in the Drug Substance field

**Responsibilities**:

- The position is responsible for the suitability of design, installation, commissioning, qualification & start-up of the MSAT laboratories and expansions thereof, in accordance with the applicable company guidelines, local codes and regulatory requirements.
- Directs the process development and manufacturing support activities in the MSAT laboratories, and is responsible for maintaining schedule and cost objectives.
- Responsible for inbound technology transfer, facility and process gap assessments, process start-up 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.
- Responsible for the integration of the MSAT laboratories into the global Bioprocess Science organization, and the strategic alignment of local MSAT activities with the global MSAT network.
- Actively liaises with external customers and internal partners to facilitate execution of customer projects.

**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
- 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)
- Willingness to travel internationally up to 10%
- Weekend work according to project plans

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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