Analytical Project Leader – Principal Scientist

vor 4 Wochen

Basel, Schweiz Lonza Vollzeit

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. Are you ready to become part of a dynamic group that supports Customers in the development of their CMC strategy and enables them overcoming some of the greatest challenges required to bring therapies to life? Apply now

Key responsibilities:

  • Lead analytical discussions with customers and interface with Subject Matter Experts (SME) representing all Analytics groups across the Lonza network including DS and DP sites

  • Set-up strategy for DPS analytical programs: Control strategy from pre-IND to BLA (QbD, ATP, QTPP, CQA assessment, ATA), specifications and justifications for specifications, analytical method lifecycle (monitoring of performances of platform methods and 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

  • Lead development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing

  • Ensure project timelines and deliverables are visible and maintained in relevant planning tools

  • Coordinate delivery of analytical milestones by liaising with relevant Analytics executional groups

  • Support Project Managers with technical review analytical SOWs and engage with SMEs as well as amendments team as required

  • Contribute to the design and set up of analytical development processes across DPS and collaborate with SMEs across the network on global initiatives related to analytical topics.

Key requirements:

  • Master degree (PhD is a plus) in Biochemistry, Pharmaceutical Sciences, Analytical Science or related field

  • At least 5 years of experience working as Analytical and/or QC Project Lead in late clinical phase projects

  • Knowledge of analytical lifecycle for biotechnology products, CMC requirements for regulatory filings (IND and BLA)

  • Very good knowledge in relevant analytical techniques and protein analytics

  • Experience working in analytical development and/or QC preferably with cGMP experience

  • Ability to interpret complex analytical data and provide solution with hands on mentality to the Customer

  • Excellent communication, reporting and scientific skills

  • Proficiency in English, written and spoken

On top of being an equal opportunity employer and value diversity at our company, we offer great benefits and a comprehensive relocation package for eligible talents

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.

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