AR&D Scientist III
AR&D Scientist III
Responsible for supporting product development trial samples testing and method development/validation for primarily stability-indicating analytical methods that are applicable to specific pharmaceutical products. 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 IND/NDA/ANDA submissions.
- Provide regular update progress reports of projects
- Support PD testing and probe stability testing for the projects
- Conduct literature searches for assigned projects. Conduct analytical research and develop analytical methods to test pharmaceutical products for conformance to established specifications.
- Develop and validate analytical test methods for assay, dissolution, impurities/degradation products, preservatives and leachables in drug products according to ICH/FDA/USP requirements under minimum to none supervision.
- Develop and validate test methods for residual solvents in drug substances/excipients according to ICH/FDA/USP requirements under minimum to none supervision.
- Conduct analytical method transfers.
- 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
- Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report under minimum to none supervision.
- Responsible for developing and executing analytical protocols (e.g. Method validation) and drafting the related test methods and validation
- 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
- Recommend and draft SOPs for general laboratory
- Prepare/review Modules and QOS for ANDA/NDA submission
- Multi-task by working on several simultaneous projects. Develop project timelines.
- Comply with all relevant regulatory requirements
- At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole
- Demonstrates ability of mentoring a team of analysts and leading assigned projects with minimal supervision while having a positive impact on personnel and colleagues.
- 5-8 years of experience in the pharmaceutical industry with BS
- 3-6 years in the pharmaceutical industry with MS
- at least 2 years in the pharmaceutical industry withPhD
- Experience with writing and editing technical documentation is preferable
- Experience working in pharmaceutical industry and/or analytical laboratory
- Strong knowledge of GMP, Industry Guidelines (ICH/FDA) and A/NDA submissions
- Good understanding of USP/NF, USP/PF and other compendia documents
- Good knowledge in the following techniques and equipment
- Assay, Related substances, Residual Solvents
- Karl Fischer, Melting point apparatus, Viscometer
- UV/Vis spectrophotometer, IR spectroscopy
- NIR, FT-IR
- Wet chemistry techniques
- USP Dissolution apparatus I, II, III, IV, rotating bottle apparatus and Franz Cell apparatus
- Bulk and Tap Density apparatus
- HPLC/UPLC with UV variable wavelength, PDA, RI, Fluorescence, ELSD, CAD detectors and LC/MS; GC
- Optical and specific rotation apparatus
- Particle size analyzers
- ICP/OES and ICP/MS
- Amount of time to Stand, Walk and Sit -100% in day