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

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

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

Lonza is a global leader in life sciences, operating across five continents. Our success stems from talented people working together to develop ideas that help businesses and improve lives. We empower our employees to own their careers and contribute solutions that make a difference in the world.

We have an outstanding opportunity within the Analytical Project Leadership team for our Contract Development and Manufacturing Organization (CDMO) branch, Drug Product Services (DPS). Are you ready to join a dynamic team supporting customers in developing their CMC strategies and overcoming challenges to bring therapies to market? Apply now!

Key responsibilities:

1. Lead analytical discussions with customers and collaborate with Subject Matter Experts (SMEs) across all Analytics groups within Lonza, including DS and DP sites.
2. Develop strategies for DPS analytical programs, including control strategies from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications, and justifications for specifications; oversee the lifecycle of analytical methods, including performance monitoring.
3. Maintain up-to-date 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 clearly tracked and maintained in relevant planning tools.
6. Support Project Managers with technical reviews of analytical Statements of Work (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 a related field.
2. Minimum of 5 years of experience as an Analytical and/or QC Project Lead in late clinical phase projects.
3. Proven knowledge of the analytical lifecycle for biotechnology products and CMC requirements for regulatory filings (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.

At Lonza, our products and services positively impact millions of lives, and we are committed to ethical practices, respecting our people and environment. We seek individuals who enjoy solving complex problems and developing innovative ideas in life sciences, offering the satisfaction of making a meaningful difference worldwide.