Associate Principal Scientist, QC
LonzaAbout the role
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.
The Principal Scientist role is the resource that addresses quality, development of methods, stability, and color developments that revolve around testing of raw materials and finished goods. Quality testing is needed to ensure that materials used during production at Lonza meets or exceeds the customers’ expectations on order quality, quantity and on-time approval for orders.
Essential Functions:
Lead team of technicians, analysts, and scientists from multiple groups including the global stability program, method development, and product development laboratories.
Lead and developed group to ensure development, professional growth, and business growth
Lead customer projects for improvement to challenges in methods and product interactions
Cultivated effective interactions with other technical groups including, analytical chemists, formulators, management, QA, regulatory, and safety personnel
Involved with interpretation of compendial monographs, internal SOP’s and writing of stability reports for hard capsule and DFS business units
Develop and validate methods to support process, product, and materials characterization
Effective interaction with other technical groups, close interactions with biologists, safety assessment scientists, analytical chemists, formulators and management
Lead a research and development group in method development and technological knowledge transfer to analytical QC group
Identify novel ingredients using multiple techniques/detectors such as mass spec, HPTLC and PDA
Keep abreast of innovative and new scientific developments in the dietary supplement/pharmaceutical industry by attending seminars, and reading relevant literature
Interpret compendia and internal monographs, and Lonza's quality policies and standards
Lead and document investigations according to established procedures and recommend corrective actions
Assure laboratory compliance by acquiring advanced knowledge in cGMP, cGLP, CFR and other regulations
Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines
Develop or revise laboratory SOPs as required
Develop and maintain a current and thorough knowledge of current regulatory policies, guidance, and expectations, as well as current industry standards and applicable corporate policies
Execute process development studies with great attention to detail
Maintain lab equipment, write and execute experimental protocols, assist in experimental design and perform data analysis in research and development labs
Purify botanical extracts through various organic techniques and novel equipment
Order capital equipment and laboratory supplies
Organize preventative maintenance contracts with outside contractors and make sure work is compl
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