Are you interested in joining a leading and well established pharmaceutical company that develops and manufactures some unique products including transdermal and thin film dosages? Our client, located in the greater Gettysburg, PA area, is looking for a Senior Analytical Scientist to join their R&D team. The Analytical Senior Scientist will be responsible for the design and development of new analytical testing methodologies and the management of testing to support assigned development programs. If you're interested in learning more, apply here or reach out directly to Hannah Ferguson at ...@germerintl.com

Essential Functions:

• Draft R&D stability protocols consistent with the stage of the project.
• Development of new analytical testing methodologies which can be implemented for setting in-process and final product specifications (assay, impurity/related substances, dissolution and residual solvents).
• Author method development protocols/ reports and assist with method validation/ verification/transfer to the Q.C. laboratory, as applicable.
• Develop and troubleshoot stability-indicating methods for drug products.
• Assist with the investigation of analytical testing results failures.
• Define test methodologies and requirements for specific analyte of interest; prepare test samples and conduct tests on in-process intermediates and/or finished products as required to support development programs; make improvements to existing testing methodologies as necessary to support development or product improvement projects.
• Anticipate and proactively address potential lab method development, method validation, clinical, regulatory and commercial testing issues during development.
• Responsible for following all relevant regulations (e.g. DEA, FDA, OSHA, EPA, DEP, etc.) and company procedures.

Job Specifications:

• B.S. in chemistry or related field with a minimum of 10 years pharmaceutical method development experience
• 10+ years experience working with HPLC, LCMS, and GC analytical methods for analysis of transdermal and/or solid oral dosage form experience; proven track record of successful analytical methods development leading to successful method validation
• 7+ years experience in analytical method validation and pre-formulation analytical work in a pharmaceutical environment.
• 7 + years experience in an FDA regulated environment as well as familiarity with 21CFR Part 211 Federal regulations.
• 5+ years experience in analytical group supporting development of ANDAs & NDAs
• Skilled technical writer and experience in writing analytical method development and validation reports