- 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.
- B.S. in chemistry or related field with a minimum of 10 years pharmaceutical method development experience.
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Senior Scientist - Red Lion, United States - Germer International - Pharmaceutical Recruiting
Description
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:
Job Specifications:
