RESPONSIBILITIES:
Responsible for developing and optimizing fit-for-purpose analytical methodologies across early through late stage product development for injectable and ophthalmic drug products.
Responsible for designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies.
Must test various samples in support of formulation development, subsequently followed by interpretation of results to provide meaningful guidance to the team.
Must verify co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.
Required to maintain and clean laboratory instruments and equipment.
Required to design and/or execute departmental methods, protocols and SOPs
Must perform other laboratory related miscellaneous duties as required.
QUALIFICATIONS:
A M.S. degree in Analytical Chemistry or related field with 7+ years of experience or a Bachelor’s degree with 9+ years of experience
3 - 4 years minimum experience supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred
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