Clinical and Scientific - Research Scientist I

Job Description: Associate Scientist, Analytical Chemistry Fort Worth Analytical, Pharma R&D

This laboratory position in the Research and Development Analytical Chemistry department provides support to Client ophthalmic drug development programs.
The selected individual will have key responsibility for analytical testing supporting a range of activities including general sample analysis, analytical method development, analytical method validation, method transfer, stability, and investigative studies to trouble-shoot issues.
The position is laboratory based and will involve support work for internal and external projects.
The individual provides analysis and evaluation of materials and products at all stages of the product development process.

SKILLS AND RESPONSIBILITIES:

Perform analytical chemistry in collaboration with others to develop and validate analytical methodology, including stability-indicating HPLC methods, GC methods, Karl Fischer for new drug substances and products.
Perform and verify compendia methods when appropriate.
Generate analytical data for new and existing methods to trouble-shoot issues.
Assists in the design and execution of clinical phase-appropriate method validation protocols.
Executes stability studies to support the development of new drug substances or drug products.
Compiles laboratory data.
Assists laboratory investigations for aberrant and out-of-specification data.
With assistance, author technical documents such as method development/validation reports, stability reports, and certificates of analysis.
Able to maintain laboratory records and provide peer review and approval of quality critical data.
Able to independently schedule work activities and maintain laboratory supplies and equipment.
Authors and/or reviews standard operating procedures pertaining to analytical testing and reporting.
Able to execute investigational studies in collaboration with others to address specific issues.
Conducts work in compliance with cGMP, safety, and regulatory requirements.
Provides analysis and evaluation of materials and products at all stages of development and for their area of focus.