(Associate) Principal Scientist Bioanalytics

(Associate) Principal Scientist Bioanalytics

Lonza

Basel, Switzerland

What you will do:

• Responsible for leading and managing pharmaceutical development projects of drug entities within Development Bioanalytics (DevBA) from various customers and in different pre-clinical development phases.
• Accountable for the successful delivery of work packages for assigned projects. This includes on-time close out/authorization and provision of required analytical testing results, documents and reports (e.g. establishment and pre-validation, non-GMP batch release and stability studies), leading investigation in compliance with ISO standards.
• Accountable to independently and proactively address risks and resolve issues of deliverables on time for mitigation, including good communication to all stakeholders potentially affected.
• Represents DevBA in Lonza internal project meetings and customer meetings for complex topics as SME (Subject Matter Expert).
• Supports the relevant stakeholder (e.g. APL) to maintain all relevant planning tools.

What we are looking for:

• A PhD degree in Biochemistry, Biotechnology, Analytical Science, or related Life Sciences field, or equivalent relevant experience, is required.
• Experience working within the Bio-Pharmaceutical industry as a research or technical expert preferably using potency assays for various modalities (Monoclonal Antibodies, Bi/trispecific Antibodies, Enzymes, Peptides, recombinant proteins, ADCs, etc…).
• Strong expertise in the set-up, optimization, transfer, and troubleshooting of cell-based assays (CBA), as well as broad knowledge of analytical techniques including mammalian cell culture and ligand-binding assays such as ELISA, enzyme assay and SPR.
• Good knowledge in guidelines for analytical methods (ICH Q14/ICH Q2).
• Excellent communication skills, team player, flexibility and ability to manage complexity.
• Fluent in English is a must. Any other languages are a plus.