Associate Principal Scientist, Quality Control

Associate Principal Scientist, Quality Control

Lonza

Visp, Switzerland

The Associate Principal Scientist in Quality Control serves as a scientific and strategic leader within the QC organization. In this role, you will oversee complex analytical projects, drive method development and validation activities, and ensure the highest standards of data integrity and regulatory compliance. You will collaborate closely with cross-functional partners - including Manufacturing, Quality Assurance, Regulatory Affairs, and MSAT - to support product release, stability programs, and continuous improvement initiatives. This position requires strong technical expertise, proven project leadership skills, and the ability to operate effectively in a fast-paced, highly regulated pharmaceutical environment.

What you will do:

• Lead and manage QC projects from planning through execution, ensuring timely delivery of high-quality analytical results;
• Develop, optimize, and validate analytical methods for raw materials, in-process controls, drug substances, and drug products in accordance with ICH and GMP requirements;
• Serve as the scientific subject-matter expert for analytical technologies such as chromatography, spectroscopy, dissolution testing, bioassays, and other QC-relevant techniques;
• Troubleshoot complex analytical or technical issues and provide expert guidance to laboratory teams;
• Review and approve analytical data, method validation protocols/reports, technical documentation, and investigation records;
• Ensure compliance with GMP, data integrity standards, and internal quality systems;
• Collaborate with cross-functional teams to support regulatory submissions, product lifecycle management, and technology transfers;
• Lead or contribute to deviation investigations, CAPAs, and change control processes;
• Drive continuous improvement initiatives to enhance laboratory efficiency, method robustness, and process standardization;
• Mentor and support junior scientists, providing technical and project-related guidance.

What are we looking for:

• PhD or Master’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline;
• Several years of experience in QC, Analytical Development, or a related field within the pharmaceutical or biotech industry;
• Strong knowledge of GMP, ICH guidelines, and regulatory expectations (EMA, FDA);
• Demonstrated experience managing complex scientific projects in a regulated environment;
• Excellent analytical, problem-solving, and communication skills;
• Ability to work independently and collaboratively within multidisciplinary teams;
• Proven ability to lead, influence, and drive results across teams and stakeholders.