Senior Project Lead Clinical Quality Control Physico Chemical Analytics (m/f/d)

at  Lonza

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Senior Project Lead Clinical Quality Control Physico Chemical Analytics.

Key Responsibilities

• Lead and manage pharmaceutical development projects of drug entities (mAB/protein) of all levels of complexity and new modalities (e.g. ADC, mRNA) within QC from various customers and in different clinical development phases up to market authorization readiness.
• Accountable for the successful delivery of QC work-packages for assigned projects, incl. proactive risk and issue management. This includes on time close out/authorization and provision of required documents and reports (e.g. stability reports), LIMS specifications, lead of change requests, CAPAs, investigation of deviation and OOX events, representing QC in internal project meetings and customer meetings for highly complex topics as SME (Subject Matter Expert).
• Maintain the cGMP quality standard for assigned processes in PhysChem QC according to applicable SOPs and current health authority/international guidelines (e.g. EMA, FDA CFR, USP, PhEur, JP, PIC/S, ICH).
• Effectively network and liaise with partner units and relevant stakeholders within the Lonza network to ensure the successful delivery of projects.
• Accountable as process owner of assigned business processes, to continuously improve and maintain compliance and act as subject matter expert in regulatory inspections and customer audits.
• Ensure Key Quality Indicators (KQI) and safety regulations are followed within the area.

Key Requirements

• MSc or PhD degree in Biochemistry, Pharmaceutics, Chemistry or related field incl. solid work experience in relevant area
• Advanced scientific working experience in protein analytics incl. sound understanding of protein degradation pathways/molecule liabilities preferably demonstrated by a proven track record within a cGMP regulated area in the pharmaceutical or chemical industry, in analytical quality control (QC) or Analytical Development of large molecule.
• Over 3 years’ working experience on the analytical lifecycle of biotechnology products, CMC requirements for regulatory filings required.
• Experience in cGMP Quality Control of Antibody-Drug Conjugates (ADC) and/or mRNA, either on Drug Substance and/or Drug Product level, is a strong advantage.
• Hands-on experience in management of quality records like deviations, CAPAs, Change Requests.
• Proactive and independent self-starter with strong focus on quality, agility on changing priorities and high level of resilience when coordinating multiple tasks simultaneously incl. good communication skills to all stakeholders.
• Business fluent written and spoken English.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference

• Lead and manage pharmaceutical development projects of drug entities (mAB/protein) of all levels of complexity and new modalities (e.g. ADC, mRNA) within QC from various customers and in different clinical development phases up to market authorization readiness.
• Accountable for the successful delivery of QC work-packages for assigned projects, incl. proactive risk and issue management. This includes on time close out/authorization and provision of required documents and reports (e.g. stability reports), LIMS specifications, lead of change requests, CAPAs, investigation of deviation and OOX events, representing QC in internal project meetings and customer meetings for highly complex topics as SME (Subject Matter Expert).
• Maintain the cGMP quality standard for assigned processes in PhysChem QC according to applicable SOPs and current health authority/international guidelines (e.g. EMA, FDA CFR, USP, PhEur, JP, PIC/S, ICH).
• Effectively network and liaise with partner units and relevant stakeholders within the Lonza network to ensure the successful delivery of projects.
• Accountable as process owner of assigned business processes, to continuously improve and maintain compliance and act as subject matter expert in regulatory inspections and customer audits.
• Ensure Key Quality Indicators (KQI) and safety regulations are followed within the area