Job Description
Lonza is a global leader in life sciences operating across five continents. Our greatest scientific solution is talented people working together to devise ideas that help businesses improve people's lives.
We have an outstanding opportunity within the Analytical Project Leadership team of Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch.
Key Responsibilities:
* Lead analytical discussions with customers and collaborate with Subject Matter Experts representing all Analytics groups across the Lonza network.
* Set up strategy for DPS analytical programs: control strategy, specifications, and justifications.
* Maintain knowledge of assigned molecules, method strategy, industry issues, and 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.
* Support Project Managers with technical review of analytical statements of work.
Key Requirements:
* Master degree in Biochemistry, Pharmaceutical Sciences, or related field.
* At least 5 years of experience as Analytical and/or QC Project Lead in late clinical phase projects.
* Proven knowledge of analytical lifecycle for biotechnology products and CMC requirements.
* Very good knowledge of 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 solutions to customers.
* Excellent communication, reporting, and scientific skills.