Perform routine wet chemical and instrumental analysis on raw materials and finished products. Develop, revise and validate analytical methods. Accurately compiles and reports data. Gather, compile and compose documents needed for regulatory submissions.
Develop, revise and validate analytical methods in support of product development and IND/NDA/ANDA filings.
Responsibilities:
- Conduct literature searches for assigned projects. Conduct analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications. Conduct analytical method validation and method transfer.
- Develop and validate analytical test methods for assay, dissolution, impurities/degradation products in drug products according to ICH/FDA/USP requirements.
- Develop and validate test methods for residual solvents in drug substances/excipients according to ICH/FDA/USP requirements.
- Perform complex routine and non-routine physical and chemical tests on raw materials, API's, in-process and finished products and test R&D trial batches and associated stability studies and generate analysis report.
- Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report.
- Responsible for developing and executing analytical protocols (e.g. Method validation) and drafting the dissolution and assay test methods and validation reports.
- Develop test methods for evaluating both the physical and chemical aspects of new pharmaceutical products.
- Maintain good documentation practices and proper laboratory notebooks and prepare ARD reports. Review other scientists' notebooks when required.
- Recommend and draft SOPs for general laboratory procedures.
- Assisting in preparation /review Modules and QOS for ANDA/NDA submission
- Provide regular update reports on progress of projects.
- Multi-task by working on several simultaneous projects.
- Perform other duties as assigned.
- Perform trouble-shooting and investigations under the direction of management.
- Comply with all relevant regulatory requirements.
- Other projects and duties as required or assigned.
Education/Qualifications:
- Bachelor's Degree in Chemistry or related scientific discipline
- Master's Degree is a plus but not essential
- 3-5 years of experience in the pharmaceutical industry with BS
- 2-3 years with MS
- Communication/Teamwork
- Internal/External Customer Focus
