Analytical Project lead Commercial QC 80-100%

Responsibilities

• 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)
• 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

Requirements

• 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
• Ready to shape the future of life sciences?

Benefits

Additional Information

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

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Company Intel

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