Principal Scientist

Title: Principal Scientist

Location: Laurelton, NY

Position Type: Full-time, non union

Salary: $115,000/year

Job Summary:

Develop and validate analytical methods for a wide range of pharmaceutical products, ensuring regulatory compliance, and supporting the development of high-quality finished products. Lead the development of robust analytical methods for Assay, Dissolution, Related Substances, and Nitrosamine Impurities techniques, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Manage the validation of analytical methods in compliance with internal Standard Operating Procedures (SOPs) and regulatory guidelines (ICH and FDA). Prepare comprehensive validation protocols and validation reports. Conduct analysis of release, in-process, and stability samples, ensuring accurate and reliable data. Compile and analyze results to identify trends and provide insights into product stability over time. Conduct multimedia dissolution studies for bioequivalent generic product development. Compare results with innovator products and generate necessary graphs for regulatory filings. Perform compatibility studies to identify suitable excipients for formulation development, ensuring the creation of high-quality finished pharmaceutical products. Oversee the calibration and maintenance of analytical instruments to ensure optimal performance and accuracy. Ensure all data generated adheres to stringent quality standards. Ensure compliance with regulatory guidelines, preparing necessary documentation for internal and external audits. Prepare detailed reports for regulatory submissions and filings.