Chemist Pharma

Charlotte, NC, United States

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Chemist - Senior Research Scientist - Analytical Research and Development - Pharmaceuticals

Perform analytical method development, method validation and method transfer
Strong knowledge on the forced degradation studies and data interpretation
Support formulation development by developing and validating suitable analytical test methods, with a focus on dissolution, HPLC and GC methods
Perform characterization of the R&D formulations and provide analytical support for studies necessary for chemistry and manufacturing controls, mentor junior scientists as needed
Draft test methods, specifications, method validation protocols and reports as per the Company SOPs and regulatory guidelines
Draft various Drug Product Risk Assessment Reports per regulatory requirement
Coordinate with the departments of product development, QC, QA, regulatory affairs and manufacturing for regulatory submissions
substances and finished products

Qualifications:

Must have advanced degree in Analytical Chemistry or other related fields
At least 7-10 years of R&D experience in pharmaceutical industry
Must have good background in analytical method development and validation for drug
Good understanding of guidelines for product development, and good GMP compliance.

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