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Senior Research Scientist
2 months ago
ThermoFisher is seeking a highly skilled and experienced Senior Research Scientist to join our team in a key role that combines laboratory operations, quality assurance, and regulatory compliance. The ideal candidate will have a strong background in chemistry, biology, or a related field, with a minimum of 6 years of experience in laboratory project management, validation, or a related field.
Key Responsibilities- Lead Laboratory Operations: Manage staff responsibilities for day-to-day laboratory operations, schedule activities to meet target dates, and ensure compliance with Good Manufacturing Practices (GMP) guidelines.
- Quality Assurance and Control: Review and approve test results, manage deviations, and implement corrective actions to ensure quality and compliance.
- Regulatory Compliance: Serve as the technical and regulatory expert, back up to key regulatory inspection contact, and participate in negotiations with clients, regulatory reviewers, and inspectors.
- Method Development and Validation: Develop, validate, and verify analytical methods for drug products and raw materials, including assay, impurity, content uniformity, residual solvent, equipment cleaning verification, and identification tests.
- Stability and Data Trending: Interpret analytical test results, manage stability data, and develop and implement policies and procedures.
- Documentation and Reporting: Draft, review, and approve method validation/verification protocols/reports, in-use study testing protocols/reports, stability testing protocols, and other reports for clients.
- Education: Bachelor's degree or foreign degree equivalent in Chemistry, Biology, or a related field of study.
- Experience: Minimum 6 years of experience as a Scientist or in laboratory project management, validation, or a related field.
- Skills: Strong knowledge of OOS/OOT investigations, chromatography, DEA controlled samples, deviation, CAPA implementation, change controls, analytical method evaluation, development, validation, and verification, stability data trending, GMP documentation practices, and regulatory compliance.
