- Chemist with background in organic, analytical or physical chemistry, who has worked in analytical method development of drug products for ANDA or 505 b(2) filings.
- This person should be well versed in common pharmaceutical analytical tools and have previous experience in validating methods as per ICH guidelines.
- In addition, they should be able to troubleshoot methods and work with formulation scientists in developing discriminating dissolution methods, identifying unknown impurities and transferring methods to the quality control (QC) laboratory.
- Suggest improvements and efficiencies in the department. Assist in revising and maintaining SOPs, operating procedures and other documents. Suggest new equipment and or training for personnel.
- 60% Daily Review, plan, design and execute experiments for analytical development & validations
- 20% Analyze data and summarize in form of reports
- 10% Review literature, reports, protocols and approve them
- 5% Discuss, prioritize and plan work with external functions such as PD and QC
- 5% Provide feedback to senior management on project progress
- MS or PhD in Analytical Chemistry or related field
- Analytical method development & validations with 3 - 6 years of experience in the generic drug industry.
- Experience in working with DEA controlled drug substances and relevant regulations.