Manager, Analytical Development - Lengnau, Schweiz - Thermo Fisher Scientific Biologics Lengnau

Thermo Fisher Scientific Biologics Lengnau

Geprüftes Unternehmen

Lengnau, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

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 troubleshoot process challenges.
Establish department metrics for testing turnaround time, firsttime 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.

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.
Broad understanding of qPCR, ELISA, Liquid Chromatography, cellbased 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.