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Manager, Analytical Development
vor 4 Monaten
Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.
**Location/Division Specific Information**
How will you make an impact?
This position will be responsible to set up the Analytical Development group at the Lengnau, Switzerland, Thermo Fisher Scientific site. Lead all aspects of analytical activities for client biologics programs.
**Key Responsibilities**:
- Build an effective analytical development team at our Lengnau, Switzerland site to support our biologics business. Hire scientists in different testing area including process and product purity/impurities, protein separation and potency assays. Provide technical and people leadership by training and mentoring new team members.
- Defining group structure, developing and empowering staff, putting staff in a position to achieve their career goals while also achieving department goals.
- Lead high level design of major biologics analytical assays. Ensure analytical methods are fit for purpose and support product development needs. Work with Process Development and Manufacturing groups to trouble-shoot process challenges.
- Establish department metrics for testing turnaround time, first-time right, and training completion.
- Write, review and approve of department SOPs, analytical protocols, reports, test methods and other documentations.
- Ensure and maintain safe laboratory environment and work practices.
- Build and maintain department resource model based on project needs.
- Act as the analytical technical lead on multiple programs, collaborate with internal and external team members to move client projects forward. Collaborate with Program Management to ensure clear expectations and successful results. Provide regular communication of analytical status to clients.
How will you get here?
**Education and Experience**
- Bachelors, Master's or PhD in biology, chemistry, biochemistry, chemical engineering, or a related field with 10, 8, or 5 years of biotech industry experiences.
- 3+ years of supervisory experience is strongly preferred.
**Knowledge, Skills, Abilities**
- Broad understanding of qPCR, ELISA, Liquid Chromatography, cell-based potency assays.
- Ability to lead and influence. Ability to foster collaboration and transparency. Strong timeline management skills.
- Excellent interpersonal, written and communication skills.
- Familiar with ICH requirements on analytical methods, stability, comparability and specification. Knowledge of biologics CMC and IND/BLA submission is preferred.
**What's in it for you?**
- We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits
- Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
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. A 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
