US-NY-Rochester: Sr. Research Scientist

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Date: 29-Jul-2008

Sr. Research Scientist, Statistics

Job Description Provides technical expertise and leadership for the global pharmaceutical, vision care, and surgical stability programs, providing analysis and trending of stability data for regulatory filings and technical assessments of stability specifications.

Job Duties: Provides technical expertise and leadership for the global pharmaceutical, vision care, and surgical stability programs, providing analysis and trending of stability data for regulatory filings and technical assessments of stability specifications.

Acquire and develop appropriate statistical software tools to interface with a laboratory LIMS system, provide suitable statistical trending of data, and generate reports and tables in formats suited for regulatory submission.

Interact with product development teams to develop stability strategies for new products that guide stability protocol development, author stability reports for regulatory submissions, and respond to regulatory agency questions.

Lead the stability programs of projects from research to development phase.

Interact with internal and external contacts at a variety of levels, including Regulatory Affairs, Analytical Research & Development, Formulations Development, Process Development, and external contract laboratories.

Oversee the design, implementation and execution of stability protocols that comply with FDA, ICH, and ISO guidance documents.

Establish expiry dating for Clinical Trial Material across all business units. Qualifications Education: M.S. or Ph.D. in Applied Statistics with a minimum of 3 years industry experience in Stability/Analytical Development.

Experience: Applicants must have experience in the statistical analysis of stability data, a strong analytical background, and a strong working knowledge of stability requirements within the pharmaceutical industry.

Special Skills: Strong statistical analysis and technical writing skills. Demonstrated success in working in a multidisciplinary team/collaborative environment. Proven organizational and project planning skills. Strong leadership skills, problem solving skills, the ability to multi-task, strong verbal and written communication skills with customer service orientation and the ability to work effectively with various functional areas within the company. Ability to develop as a stability subject matter expert on stability guidance documents, best practices, and emerging trends.

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