Associate Principal Scientist / Analytical Project Leader
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland 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 position as Principal Scientist / Analytical Project Leader.
- Lead analytical discussions with customers and interface with subject Matter Experts (SME) representing all DPS Analytics groups
- 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 Leads with analytical SOWs and engage with SMEs as well as amendments team as required
- Set-up strategy for DPS analytical programs: Control strategy, specifications, analytical method lifecycle, platform methods/ product-specific methods
- Maintain up-to-date knowledge of assigned molecules as well as method strategy, industry issues/trends and pharmacopeia
- 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).
- Contribute to the design and set up of analytical development processes across DPS
- Adhere to cGMP regulations as required
- PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Work experience in analytical development and/or QC, preferably with cGMP experience
- Good working knowledge in all relevant analytical techniques
- Experience with parenteral dosage forms and protein analytics
- Ability to interpret complex analytical data
- Capability to work independently and in a team environment
- Excellent communication, supervisory, reporting and scientific skills
- Fluency in written and spoken English
- Experience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired
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.