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Senior Research Scientist
at Lisa Wilson in New York
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.
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.
Published at 11-08-2008
Viewed: 37 times
Viewed: 37 times