Lead product development activities such as, but not limited to, analytical method development, pre-validation, method transfer, analytical support to formulation and process development studies, and stability testing with minimal supervision.
Proficient in method development, pre-validation, and method transfer.
Provide analytical support to formulation and process development studies.
Understands and applies scientific principles and technology, and demonstrates knowledge of relevant regulatory requirements.
Maintains proper documentation records and analyzes and interprets analytical data independently and efficiently.
Demonstrates effective communication skills, strong research capability and problem solving skills.
Highly experienced in analytical wet chemistry and techniques such as, HPLC, GC, Dissolution, Mass Spectroscopy, and physicochemical analysis. Subject matter expertize in one or more areas in desired.
Experience developing chromatographic methods for use in characterization of pharmaceutical drug substances and dosage forms.
Familiarity with appropriate ICH guidelines, FDA guidance for industry, and USP monographs relating to characterization and specification requirements for marketed drug products.
Strong trouble shooting and problem solving skills.
Advanced computer literacy, technical writing, multi-tasking, communication and prioritization skills.
Bachelor’s degree in chemistry or closely related field and at least 10 years of pharmaceutical or related laboratory experience, or
Master’s degree in chemistry or closely related field with 7 years of pharmaceutical or related laboratory experience, or
Ph.D. in chemistry or pharmaceutical science or closely related field and 4 years of pharmaceutical or related laboratory experience.