Manager, Analytical Development

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.

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, 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.