Sr Scientist QA Operations

vor 7 Monaten


Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

**Work Schedule**

Other

**Environmental Conditions**

Office

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

As part of the QA Operations Team of Fisher Clinical Services GmbH, Lengnau (LGN), the position holder is responsible to review and release recombinant Drug Substance including purchased material, internally manufactured material and intermediates. During the period of establishing the new manufacturing site, the position holder will be part of the facility program and will have to support the implementation of the necessary systems within the facility. In particular the position holder will have support different departments (such Manufacturing, Quality Control, Supply Chain, Engineering).

**Operational axis**:

- During Project Phase: Implementation of Manufacturing Execution System (MES) with regards to QM processes, including ‘Review by Exception’ concept
- Review and approval of operational elements such as procedures and related documents including specifications
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date.
- Be on the floor during critical manufacturing steps
- Respect and share data integrity rules (ALCOA+)
- Make proposal to improve flows, manufacturing activities and organisation

**Background and skills**:
Pharmacist, scientific with master degree or higher. At least 3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release.

Knowledge of pharmaceutical manufacturing processes with particular on biologic drug substance

Fluent communication (oral and written) in German and English.

Experience in SAP and electronic MES (manufacturing execution system) is an asset.

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**:



  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that...

  • Scientist, QA Systems

    vor 7 Monaten


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing...

  • Manager, QA Systems

    vor 4 Monaten


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards **Manager, QA Systems & Compliance**: Thermo Fisher Scientific Inc. Lengnau is seeking an exceptionally qualified individual with a strong track record and experience in managing QA Systems & Compliance to join our team...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office Thermo Fisher Scientific - The Lengnau site is a part of the Drug Substance Division, a world-class contract development and manufacturing organization (CDMO) that is revolutionizing the industry. We are seeking a Sr Manager, Manufacturing Engineering to join our exceptional team in...

  • Senior QA Sterility SME

    vor 2 Monaten


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Work Schedule Standard (Mon-Fri) Environmental Conditions Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Job summary: This position is expected to be the QA – Sterility Assurance Lead (Senior QA Sterility SME) for the entire site. Oversees, runs, and ensures the...

  • Scientist, QA Systems

    vor 7 Monaten


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing...

  • QA Validation Expert

    vor 7 Monaten


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Thermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through...

  • Sr Business Manager

    vor 3 Wochen


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard Office Hours (40/wk) **Environmental Conditions** Office Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving...

  • Sr Business Manager

    Vor 5 Tagen


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsOfficeJob DescriptionThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    The Director, Process Development manages a large team of scientists, supervisors and managers that are assigned to a more than one functional area and/or site. Responsible for overseeing the global alignment, strategic growth and continuous improvement of their department to align with long term strategy of the business unit and company. Accountable for the...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials Thermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. - Location**:Lengnau (Bern) -...


  • Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices (GMP) Safety Standards When you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the...

  • Director Engineering

    vor 7 Monaten


    Lengnau, Schweiz Thermo Fisher Scientific Vollzeit

    **Position Summary**: **Key Responsibilities**: - Coordinates and prioritizes the design, construction and qualification of new biologics production assets in the Lengnau facility. - Builds, structures and advises an organization to assist in the construction and qualification of the GMP site. - Generates, plans and drives multi-project facility master plan...