Senior GMP Validation Scientist – Validation Strategy & Documentation Physico-Chemical Quality Control 80-100% (m/f/d)

The actual location of this job is in Basel Stücki, Switzerland.

For our successful Drug Product (DP) focused branch located in Basel 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 Senior GMP Validation Scientist Validation Strategy & Documentation position.

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:

• Evaluate new analytical test methods during pre-validation activities (e.g. compare requirements of methods with existing laboratory equipment)

• Transcribe test methods per Lonza requirement and support setting up the laboratory (e.g. ordering required material)

• Independently and effectively conclude validation, transfer or verification incl. planning and documentation (protocol and report generation)

• Efficient communication to achieve alignment internally, within a global network, with customers and other stakeholders during review/approval processes

• Proactive stakeholder management, also cross-functional, by transparently communicating risks for validation stages against agreed timelines including proposals for risk mitigation and management

• CDS Empower folder and method management as Power User

• Responsible to ensure compliance and up to date training status fulfilled for tasks required

• Assist in investigation/troubleshooting by proactively driving the investigation and proposing mitigation measures

• Participate and initiates improvement initiatives (e.g. on LEAN white belt level)

What we are looking for:

• BSc/MSc analytical chemistry, biochemistry or related field or Training on the job as a lab technician (EFZ, HF, CTA, BTA, PTA)

• Extensive working experience in a research/ technical role in the pharmaceutical or chemical industry, in analytical quality testing (QC)

• Proven track record to apply the most of analytical methods required within a QC or GMP regulated laboratory

• Advanced scientific knowledge of Phys-chemical analytical methods performed in the lab

• Expert experience with laboratory specific software (e.g. CDS Empower) is highly advantageous

• Advanced knowledge in comprehensive reporting, interpretation and documentation of scientific results including related presentation skills

• Good communication and inter-personal skills, Ability to work independently in a team

• Good knowledge of written and spoken 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.