Analytical Project Leader
vor 7 Stunden
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Today, Lonza is a global leader in life sciences operating across three 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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland, we have an exciting opportunity within the Analytical Project Leadership team. Become part of a dynamic group that supports Customers in the development of their CMC strategy and enables them to overcome some of the greatest challenges required to bring therapies to life.
Key Responsibilities:- Lead analytical discussions with customers and interface with Subject Matter Experts (SME) representing all DPS Analytics groups.
- Set up strategy for DPS analytical programs: product control strategy, specifications, analytical method lifecycle, platform methods/product-specific methods.
- Maintain up-to-date knowledge of assigned molecules, method strategy, industry issues/trends, and pharmacopeia as well as adhere to cGMP regulations.
- Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP, specifically including HPLC and CE purity methods, content by UV, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection).
- Ensure project timelines and deliverables are visible and maintained in relevant planning tools.
- Oversee delivery of analytical milestones by liaising with relevant DPS Analytics executional groups.
- Support Project Managers with the technical review of the analytical SOWs and engage with SMEs as well as the amendments team as required.
- University degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field (PhD is a plus).
- Very good knowledge in protein analytics, all relevant analytical techniques and parenteral dosage forms.
- Ability to interpret complex analytical data.
- Experience working in analytical development and/or QC preferably with cGMP experience.
- Knowledge of analytical lifecycle for biotechnology products, CMC requirements for regulatory filings, and working in a matrix organization highly desired.
- Excellent communication and scientific skills.
- Solution-oriented mindset.
- Fluency in English, written and spoken.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Reference: R61283
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