Analytical Project Leader – Principal Scientist (f/m/d)

The actual location of this job is in Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five 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.

Opportunity

For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, we have an outstanding opportunity within the Analytical Project Leadership team. Are you ready to become part of a dynamic group that supports customers in developing their CMC strategy and overcoming some of the greatest challenges to bring therapies to life? Apply now!

Key Responsibilities

1. Lead analytical discussions with customers and collaborate with Subject Matter Experts (SMEs) across all Analytics groups within the Lonza network, including DS and DP sites.

2. Develop strategies for DPS analytical programs: control strategy from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications and justifications, and analytical method lifecycle management.

3. Maintain current knowledge of assigned molecules, method strategies, industry issues/trends, pharmacopeia, and ensure compliance with cGMP regulations.

4. Lead the development and evaluation of analytical methods and technologies to support formulation development and drug product testing.

5. Ensure project timelines and deliverables are tracked and maintained using relevant planning tools.

6. Support Project Managers with technical reviews of analytical SOWs and collaborate with SMEs and amendments teams as needed.

Key Requirements

1. Master's degree (PhD preferred) in Biochemistry, Pharmaceutical Sciences, Analytical Science, or related fields.

2. At least 5 years of experience as an Analytical or QC Project Lead in late clinical phase projects.

3. Proven knowledge of analytical lifecycle management for biotechnology products and CMC regulatory filing requirements (IND and BLA).

4. Strong expertise in relevant analytical techniques and protein analytics.

5. Experience in analytical development and/or QC, preferably with cGMP experience.

6. Ability to interpret complex analytical data and provide practical solutions with a hands-on approach.

7. Excellent communication, reporting, and scientific skills.

Every day, Lonza’s products and services positively impact millions of lives. We see this as both a privilege and a responsibility. Our success depends on respecting and protecting our people and our environment. Achievements are meaningful only when achieved ethically.

People come to Lonza for the challenge and creativity in solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction of making a meaningful difference worldwide.