The main role of the analytical chemist is to develop new analytical methods for products under development.
Develop robust analytical methods for products under development and provide continuous support from feasibility to scale up of the products in order to facilitate timely ANDA submissions.
Validate various analytical methods (from Raw material to Finished product) using different analytical techniques required in order to have ready to use analytical methods for internal (for e.g. QC) & external laboratories.
Transfer the validated analytical methods to external labs (within DRL sites US/India or CMOs)., identify the critical parameters involved & troubleshoot when and as required in order to facilitate smooth method transfer and support product testing.
Maintain GLP (good laboratory practices) & GDP (good documentation practices) in the analytical laboratory in order to adhere to SOPs, quality, compliance and DEA regulations.
Good knowledge on guidance and expectations from Regulatory Agencies, in particular, USFDA is essential. In-depth knowledge in basic principles and hands-on experience on HPLC, UPLC, UV spectrophotometer, IR spectrometer, etc.
BS with minimum of 5 of relevant work experience years; M.S. in Chemistry 3 - 6 years of generic formulation experience in a pharmaceutical environment highly preferred.
Good communication (written & verbal), interpersonal, and organization skills
Good computer skills including experience with MS Office Suite
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.