Analytical Chemist

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 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.

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