Lonza seeks a Project Lead for Quality Control in Stein, Switzerland. This full-time hybrid role focuses on managing QC projects for biologics and ADCs, ensuring GMP compliance and successful method transfers.
The company is looking for a professional to serve as the main Quality Control liaison for clients. This position involves evaluating laboratory capabilities and overseeing the transfer of analytical methods to guarantee the effective execution of release and stability testing for commercial and late-phase biologic products. The individual will collaborate with program managers and cross-functional groups to manage schedules, provide technical direction, and ensure all deliverables meet regulatory standards.
Responsibilities
- Direct and organize Quality Control project tasks related to the release and stability testing of large molecule drug products and Antibody Drug Conjugates (ADCs) during the PPQ and commercial phases.
- Act as the central Quality Control figure for projects, ensuring smooth execution by aligning timelines, deliverables, and communication with stakeholders and customers.
- Evaluate laboratory capacity and handle the transfer of analytical methods to ensure testing is implemented promptly to satisfy project needs.
- Develop and apply analytical testing strategies, including assessing method suitability, evaluating performance, defining control strategies, and establishing specifications.
- Prepare and maintain quality documentation, such as Standard Operating Procedures (SOPs), source documents, reports, deviation records, and change requests in compliance with cGMP.
- Represent Quality Control as a subject matter expert during internal and external audits, inspections, and customer meetings, ensuring full regulatory readiness and documentation compliance.
Requirements
- Proven experience working in a Good Manufacturing Practice (GMP) regulated pharmaceutical Quality Control setting, with a solid grasp of analytical testing for biologics and large molecules.
- Excellent interpersonal and stakeholder management abilities, including the confidence to coordinate activities, offer constructive feedback, and engage effectively with both internal teams and external clients.
- Native-level fluency in English.
- A university degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a closely related life sciences field.
Nice to have
- Prior experience in project coordination, analytical method validation, or method transfer processes.
- Fluency in the German language.
What the company offers
- Relocation support is provided for eligible candidates and their families when necessary.
- Opportunities for agile career development within a dynamic work environment.
- An inclusive and ethical workplace culture.
- Compensation structures designed to recognize high performance.
- A competitive salary package.
- A wide range of lifestyle, family, and leisure benefits.
- The flexibility to work remotely for up to 20% of working time.
About the company
Lonza operates more than 30 sites across five continents, employing globally connected teams dedicated to manufacturing medicines. The organization is built on core values of Collaboration, Accountability, Excellence, Passion, and Integrity. Lonza actively values diversity and is committed to fostering an inclusive environment for all employees.
- Global presence with over 30 sites worldwide.
- Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
- Commitment to diversity and an inclusive workplace.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.