Senior Scientist III, Biologics, Physico-Chemical Analytics
The Senior Scientist in the will work within the Physico-chemical Analytics Team of the Analytical Development and Characterization organization to develop, qualify, and validate methods for the analysis and characterization of therapeutic protein products in late stage development.
- Design, execute, and interpret experiments to develop, optimize and validate analytical methods for biologic products in late-stage development up to commercialization.
- Support drug substance process development and drug product formulation and process development, including characterization of the process and finished product.
- Support drug substance and drug product impurity characterization and identification.
- Generate protocols, data, or review and approve analytical data to support clinical development programs (release and stability).
- Based on above, summarize results in technical reports, presentations, and regulatory documents as needed.
- Interface with cross-functional areas and CMC project teams to drive project milestones.
- Contribute to establishing best practices in the Physico-chemical Analytics laboratories.
- Implement innovative analytical technologies to characterize biologic therapies.
- Maintain and enforce safe laboratory practices and environment.
- Interact effectively with members of the Analytical Development and Characterization department at the site and across the globe, and with other project stakeholders (Quality, Regulatory CMC, Technical Project Management, others).
- Work with cross-functional groups to drive project goals to timely completion EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Ph.D. in Analytical Chemistry or related discipline with a minimum of 3 yrs experience in analytical development in the biopharmaceutical industry
Alternate: MS with 10+ years of relevant industrial experience.
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