- Develop analytical methods for the testing pharmaceutical ingredients and finished product for products that are developed in house or site transferred into this facility
- Participate in the development of protocols, methods and final reports and perform validation of analytical methods in accordance with current FDA guidelines. Participate in the transfer of validated methods to QC
- Review USP/EP for changes to current methods and specifications. Assure these changes are tested and implemented as required
- Source any needed equipment and materials for the methods/protocols
- Work with R&D Product Development on testing new formulations
- Generate data and documentation to support Regulatory Affairs
- Test samples for stability/pilot lots and for the on-going stability program
- Operate, troubleshoot and maintain analytical equipment used in laboratories, such as: HPLC, Karl Fisher, GC, FTIR, and dissolution apparatus
- Accurately document all data in compliance with GMP
- Maintain contact with all company personnel, Technical Consultants, Vendors, Service Contract Personnel and Outside Affiliations.
- 1 – 3 years of analytical, research, or equivalence laboratory is required.
- 3 - 5 years is desirable
- Experience with method development and/or method validation is required.
- Essential : Bachelor of Science degree is required.
- Desirable : Bachelor of Science in Chemistry, Analytical Chemistry, Organic Chemistry, or Biochemistry.
- Experience writing in laboratory notebooks, protocols and result reports.
- Experience with HPLC.
- Chromeleon software preferred