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 Posted: Tue Jul 29, 2008 4:16 pm Post subject: US-NY-Rochester: Sr. Research Scientist |
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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.
Thank you,
BioTech FYI Center
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