Analytical Project lead Commercial QC 80-100% — Lonza

Descrizione completa

The actual location of this job is in Basel Stücki, Switzerland. What you will get

• An agile career and a dynamic work culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance What you will do:
• Lead and manage pharmaceutical projects of drug entities within commercial QC from various customers which are in late clinical development or commercial. This includes authoring and reviewing 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. This includes 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. This includes processing of associated documents and proactive management of risks/issues.
• Acts as a single point of contact for assigned projects within commercial QC.
• Represents commercial QC in Lonza internal project meetings and customer meetings for complex topics as SME (Subject Matter Expert).
• Effectively networks and liaise with partner units and relevant stakeholders within the Lonza network to ensure the successful delivery of projects.
• Reviews and approves 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 the definition of potential Critical Quality Attributes and the analytical control strategy What we are looking for:
• 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 About Lonza 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. Ready to shape the future of life sciences? Apply now. Lonza is a global leader in pharma and biotech manufacturing. The company operates major production facilities in Visp (Valais), Basel, and Stein (Aargau), Switzerland.