Summary:
The Analytical R&D Scientist is responsible for developing and establishing new analytical methods using advanced techniques that meet FDA standards. This role may be performed independently or under the supervision of a Senior Scientist. The primary focus is on developing analytical methods for oral solids, liquids, and semi-solids intended for FDA applications. The Analytical R&D Scientist will work both on the bench and in project management, collaborating with fellow scientists and other departments to meet project objectives.
Responsibilities:
- Develop and/or validate analytical test methods, including HPLC/GC, and optimize existing methods, either independently or under the guidance of a Manager.
- Conduct analytical testing on R&D batches and stability studies, and generate stability analysis reports.
- Analytical testing includes Assay, preservative content, LOD, water content, identification tests, dissolution, disintegration, residual solvents, and related substances.
- Provide mentorship, training, and guidance to junior staff, contributing to their professional development.
- Perform experiments and studies such as reverse engineering, compatibility studies, and degradation studies independently or under a Senior Scientist's supervision.
- Assist in writing protocols, reports, and technical documents related to development, validation, and studies.
- Ensure compliance with DEA regulations and site requirements for handling, using, and disposing of controlled substances.
- Maintain adherence to company policies, SOPs, and FDA guidelines, as well as other applicable regulatory standards.
Requirements:
Education and Experience:
- Bachelor's Degree (BA/BS) in Chemistry or a related pharmaceutical science, with at least 5 years of experience in analytical method development and validation.
- Master's Degree (MS/MA) in Chemistry or a related pharmaceutical science, with at least 3 years of experience in analytical method development and validation.
- Strong knowledge of Good Manufacturing Practices, FDA/ICH Guidelines, and compendial references (e.g., USP, Ph. Eur.).
- Experience with laboratory instrument data acquisition software (e.g., Empower, Chemstation).
- Familiarity with Laboratory Management Systems (e.g., Labvantage).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).