Sr. Principal Scientist / CMC Lead

This position will work within our Vision Care function. The Dry Eye and Ocular Health CMC lead will be responsible for leading a cross functional product technical development team. Development will consist of: Pharmaceutical Development, Formulation/ Process Development, Analytics, Clinical Manufacturing and/or non GMP Pilot Operations.
•\tAccountable for the optimal set up of people, assets, and equipment to best serve project needs according to priority and timely delivery of high quality products and solutions.
•\tServe as a key execution leader accountable for developing a product and transferring the technology to our Tech Ops team.
•\tResponsible for integrating all of the required CMC documents and files and ensuring that regulatory filings to health authorities are appropriately supported.
•\tDevelopment of new product R&D efforts in the Dry Eye arena while establishing close collaboration with all of the functional teams involved.
•\tResponsible for converting the technology into the actual product
•\tCollaborates with Dry Eye Ideation Team in order to take over and advance the projects from concept to final products.
•\tHighly knowledgeable of industry best practices with the ability to introduce simplified practices within the function.
•\tContributes to definition and implementation of the global department strategy.
•\tEnsures that both strategic and operational objectives for the global line function are met or exceeded by setting appropriate priorities for the team.
•\tEnsures development of adequate Drug Substance/Drug Product manufacturing processes, formulations and/or analytics.
•\tEnsures execution of and provides required infrastructure for manufacturing of bulk clinical supplies for development pipeline projects
•\tEnsures high quality transfer of processes and methods to Tech Ops team as needed to ensure a timely product launch.
•\tEnsures best-in-class partnership with third party vendors.
•\tEnsures best practice sharing, knowledge exchange, and cross-functional support within the team and with partner organizations in R&D and beyond (e.g. QA, Regulatory, etc.).
•\tWrites relevant CMC sections of regulatory submissions.
•\tEnsures compliance to all relevant standards (e.g. HSE, GMP, etc).
•\tEnsures that all solutions and products are delivered in compliance with all relevant corporate and legal guidelines on HSE and quality requirements.
Posting Title
Sr. Principal Scientist / CMC Lead

Minimum requirements
•\tFluent in verbal and written English communication skills.
•\tBachelor's degree in a related field with 7+years of directly related working experience OR equivalent combination of education and work experience.

Job Type
Full Time

Country
USA

Work Location
Duluth, GA

Functional Area
Research & Development

Division
ALCON

Business Unit
RESEARCH & DEVELOPMENT AL

Employment Type
Regular

Company/Legal Entity
Alcon Research, Ltd.

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.


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