Support Sovereign's analytical development activities to achieve successful design, filing, transfer and launch of 505(b)2, ANDA and OTC products.
Perform release and stability testing for raw materials and drug products
Execute method transfers and method equivalency studies
Conduct method validation experiments as per written protocols
Perform characterization of physical and chemical characteristics of drug product and raw materials
Peer review laboratory notebooks, data, protocols and reports
Understand applicable cGMP, DEA regulations and Quality Procedures
Perform other tasks as assigned.
Advanced degree with Chemistry background, Masters preferred
2-5 years experience in pharmaceutical laboratory
Operation of HPLC and efficient with Empower 3 Software
Compendial/Non-compendial testing of raw materials
Adhere to all laboratory requirements in accordance with SOPs and regulatory practices such as GMPs, GDPs, GLPs, and OSHA regulations
Understanding of Analytical Chemistry including but not limited to HPLC, Dissolution, UV/Vis, FTIR, Sample Preparation Techniques, GC, Titration/electrode chemistry
Effective communication skills, written and verbal