Lead Analyst​/Specialist Commercial QC

Lead Analyst/Specialist Commercial QC 80-100%

Location:

Basel Stücki, Switzerland

• An agile career and a dynamic work culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance

• Ensure the successful and timely delivery of QC work packages for assigned projects.
• Review and approve assay documentation under cGMP following applicable SOPs and Good Documentation Practices (GDP) in a right first time and timely manner.
• Maintain up-to-date knowledge of analytical method capabilities for assigned projects.
• Take ownership for actions required by quality events under cGMP (e.g., SST failures / OOx / investigations / Deviations, CAPAs).
• Investigate and troubleshoot methods, initiate and lead lab equipment issues independently by proactively driving the investigation and proposing mitigation measures.
• Draft documents, e.g. method SOPs, validation protocol, validation report, reagent qualification report.
• Initiate or drive laboratory operational optimization and process improvement initiatives.
• Offer expert guidance to team members on analytical methods.

• Training as lab technician (e.g. EFZ, CTA), BSc or MSc in Analytical Chemistry, Biochemistry or related field.
• Extensive proven experience working in a GMP-regulated QC laboratory, with a strong focus on advanced analytical techniques e.g. HPLC, CE‑SDS, icIEF, ELISA, SPR / biacore.
• Knowledge of regulatory requirements and analytical lifecycle for biotechnology products and CMC requirements.
• Strong communication and interpersonal skills with a proactive attitude.
• Detail‑oriented and able to work in a matrix organization.
• Experience with LIMS, QC assay review, Empower, reporting, Track Wise.
• Trained investigator for OOX and deviations, changes and CAPAs.
• In‑depth understanding of cGMP, GDocP, and Data Integrity principles.
• Excellent written and verbal communication skills in English.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R76609