Senior Scientist

Our client, an established pharmaceutical company in South Central Pennsylvania, is looking to add a Senior Analytical Scientist to their team. This professional will collaborate with internal and external stakeholders to provide generic and branded products to patients.

Essential Functions:

• 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).
• Draft R&D stability protocols consistent with the stage of the project.
• Author method development protocols/ reports and assist with method validation/ verification/transfer to the QC. laboratory, as applicable.
• Develop and troubleshoot stability-indicating methods for drug products.
• Assist with the investigation of analytical testing results failures.
• Design & conduct analytical testing on lab and production scale materials; draw valid conclusions upon analysis of technical data from experimental testing, expertise, and literature references.
• 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.
• Transfer analytical methods to QC chemists.
• 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.