Asc Dir Manufacturing Process Development

How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.
THIS POSITION IS LOCATED IN SUFFERN, NEW YORKSet and implement goals, objectives, and strategy for Process Development and Improvement activities at contract manufacturers.
Ensure that contract manufacturers manage projects to the highest level of timeliness.
Project Technical Leader (PTL) for the technology transfer of new and existing products at contract manufactures.
Oversee and collaborate with Technical Support activities at contract manufacturers for marketed products. Technical Support activities include:
process/ formulation optimization
process validation
raw material/API qualification and strategic sourcing
technical process investigations
Assess for Novartis Supplier Quality the impact on process robustness and validation when changes and improvements are proposed at contract manufacturers. Also assess the impact of manufacturing deviations.
Support Novartis Supplier Quality's recommendations and mandates to improve processes and procedures at contract manufacturers
Facilitate decision making between Novartis Supplier Quality and QA departments at contract manufacturers.
Provide a high degree of scientific expertise and oversight for process development and improvement activities at contract manufacturers.
Keep abreast of trends in process technology in the pharmaceutical industry.
Ensure a high level of GMP and HSE compliance to projects associated with technical functions at contract manufacturersQualifications
B.S. / M.S. or B.S. / Ph.D. in Pharmacy or Chemical Engineering. Ph.D. highly preferred.Experience: 10+ years experience in pharmaceutical development and manufacturing process technology. Previous management and pharmaceutical R&D experience highly desired.
Highly competent in pharmaceutical formulation and process development skills
Highly competent in technical and compliance aspects of process validation
Highly competent in keeping abreast with pharmaceutical process technology trends
Highly competent in generating and overseeing high quality technical reports
Highly competent in project management
Highly competent in cross-functional communication and negotiation
Competent in pharmaceutical compliance and regulatory policies
Competent and self-motivating in developing and driving strategic objectives, projects, and systems within group and cross-functionally.
Competent in managing people: leading and directing
Novartis is committed to embracing and leveraging diverse backgrounds.
Novartis is an equal opportunity employer M/F/D/V.