A. Successful candidate will be responsible for carrying out analytical method development/validation activities and testing for oral dosage formulations.
B. MAJOR DUTIES/RESPONSIBILITIES:
Develop and validate analytical methods and perform testing using a variety of technologies including HPLC, UPLC, GC, Dissolution, UV, etc.
Perform wet chemistry and chromatographic analytical activities to support in-house formulation screening and development. Carryout associated stability studies.
Author analytical protocols, development/validation/testing reports, methods, SOPs and submission documents.
Maintain proper instrument calibration status.
Plan and execute projects in support of departmental needs.
Actively participate in the preparation of regulatory submission dossier with focus on CMC module and analytical package.
Independently solve analytical problems and develop solutions.
Comply with company policies and standards
Provide training to individuals in junior positions.
Perform other duties as assigned.
Strong hands-on experience in analytical instruments, such as HPLC, UPLC, dissolution, GC, UV, Empower, etc.
Working experience with analytical method development and validation on API and finish product, prior hands-on experience in analysis of softgel capsules is preferred
Excellent written and verbal communication, a team player
Good knowledge of cGMP, ICH and other FDA or international guidance and regulations. Prior working experience in ANDA/NDA submission package preparation is a big plus
Demonstrate compliance with procedures and policies.
Strong attention to detail
D. MINIMUM/PREFERRED REQUIREMENTS:
Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences or related scientific fields required; advance degree is a big plus.
Minimum two years of pharmaceutical R&D experience is required.