Analytical Project lead Commercial QC

The actual location of this job is in Basel Stücki, Switzerland.

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

• Lead and manage pharmaceutical projects of drug entities within commercial QC from various customers which are in late clinical development or commercial.
• Author and review complex GMP documents and advanced project documents (e.g. specifications, protocols, reports, APQR).
• Ensure the successful and timely delivery of QC work packages for assigned projects.
• Provide on-time close out/authorization and provision of documents and reports (e.g. transfer, validation, batch release, stability), LIMS specifications, lead of change requests, CAPAs, investigation of deviation and OOX events.
• Independently and proactively address risks and resolve issues of deliverables on time for mitigation, including good communication to all stakeholders.
• Responsible for end-to-end completion of sample lifecycle for assigned projects from sampling to disposal including material reconciliation in collaboration with Lab Support Team and Sample Management Team. Process associated documents and proactively manage risks/issues.
• Act as a single point of contact for assigned projects within commercial QC.
• Represent commercial QC in Lonza internal project meetings and customer meetings for complex topics as SME (Subject Matter Expert).
• Effectively network and liaise with partner units and relevant stakeholders within the Lonza network to ensure successful delivery of 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 to support definition of potential Critical Quality Attributes and the analytical control strategy.

• MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• Experience in Analytics or Quality Control under cGMP regulations.
• Proven project management success.
• 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.
• Business fluent English, written and spoken.
• Excellent written and verbal communication skills in English.

We value diversity and are committed to an inclusive environment for all employees.