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

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

Location: Basel, Switzerland. Relocation assistance available for eligible candidates and their families.

Today, Lonza is a global leader in life sciences operating across five continents. Our success is driven by talented people working together, devising ideas that help businesses and improve lives. We value our employees' careers and encourage innovative ideas that genuinely make a difference.

For Drug Product Services (DPS), our Contract Development and Manufacturing Organization (CDMO) branch, we have an outstanding opportunity within the Analytical Project Leadership team. Join us to support customers in developing their CMC strategies and overcoming challenges in bringing therapies to life. Apply now!

Key responsibilities:

• Lead analytical discussions with customers and collaborate with Subject Matter Experts (SMEs) across all Analytics groups in the Lonza network, including DS and DP sites.
• Develop strategies for DPS analytical programs: control strategies from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications, and justifications, as well as managing the analytical method lifecycle.
• Maintain up-to-date knowledge of assigned molecules, methods, industry issues/trends, pharmacopeia, and adhere to cGMP regulations.
• Lead development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing.
• Ensure project timelines and deliverables are tracked and maintained in relevant planning tools.
• Support Project Managers with technical review of analytical SOWs and collaborate with SMEs and amendments team as required.

Key requirements:

• Master's degree (PhD preferred) in Biochemistry, Pharmaceutical Sciences, Analytical Science, or related field.
• At least 5 years of experience as an Analytical and/or QC Project Lead in late clinical phase projects.
• Proven knowledge of analytical lifecycle for biotechnology products and CMC requirements for regulatory filings (IND and BLA).
• Strong knowledge of relevant analytical techniques and protein analytics.
• Experience in analytical development and/or QC, preferably with cGMP experience.
• Ability to interpret complex analytical data and provide practical solutions with a hands-on approach.
• Excellent communication, reporting, and scientific skills.

At Lonza, our products and services positively impact millions worldwide. We value ethical achievement and respect for our people and environment. Join us to solve complex problems and develop innovative ideas in life sciences, making a meaningful difference in people's lives.