Scientist II, Analytical Development

Role: Scientist II, Analytical Development at ADMA Biologics, focused on developing and validating analytical and bioanalytical assays for biologic products. Responsibilities include designing, qualifying, and validating assays per regulatory guidelines, writing SOPs, performing and supervising assay work, analyzing data with statistical tools, interpreting results, and ensuring documentation accuracy. The role involves utilizing techniques like HPLC, spectroscopy, ELISA, and others, and proposing process improvements and automation. Requirements: Master's degree in Chemistry, Biochemistry, Biological Sciences, or related field, with at least 5 years (Master's) or 3 years (PhD) of relevant experience; expert knowledge of assay development and validation; adherence to FDA and cGMP regulations. Preferred qualifications include experience with regulatory submissions and assay development for biologics. HighValue: biologics, assay development/validation, cGMP, FDA compliance, analytical techniques, bioanalytical methods, regulatory support. WorkSetup: based in Boca Raton, FL, with a focus on scientific creativity, collaboration, and independent problem solving.