The actual location of this job is in Basel Stücki, Switzerland.
For our successful Drug Product (DP) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the Principal Scientist Analytical Project Leader position.
What you will get:
* An agile career and a dynamic work culture
* An inclusive and ethical workplace
* Compensation programs that recognize high performance
What you will do:
* Lead analytical discussions with customers and interface with Subject Matter Experts (SME) representing all DPS Analytics groups
* Set-up strategy for DPS analytical programs: Control strategy from pre-IND to BLA, 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)
* 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 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
What we are looking for:
* 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
* Fluency in English, written and spoken
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.