Analytical Project Manager

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Lonza Vollzeit

About the Job:



We are seeking a highly skilled Analytical Project Leader to join our dynamic team at Lonza. As a key member of the Drug Product Services (DPS) Analytical Project Leadership team, you will play a critical role in supporting customers in the development of their CMC strategy and helping them overcome the challenges required to bring therapies to life.





  • Lead analytical discussions with customers and interface with Subject Matter Experts (SMEs) representing all DPS Analytics groups.

  • Set-up strategy for DPS analytical programs, including 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, while adhering to cGMP regulations.

  • Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP), including HPLC and CE purity methods, content by UV, color, clarity, and opalescence, pH, osmolality, extractable volume, CCI, and 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 amendments teams as required.



Requirements:





  • University degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a 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 is highly desired.

  • Excellent communication and scientific skills.

  • Solution-oriented mindset.

  • Fluency in English, written and spoken.



About Us:



Lonza is a global leader in life sciences, operating across three continents. We work in science, and 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.



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.

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