Scientist II, Analytical Research & Development

Responsibilities

• Develop, qualify, and validate phase-appropriate characterization methods using analytical techniques including, but not limited to, high-performance liquid chromatography (HPLC), gel permeation chromatography (GPC), and dissolution for one or more drug products from early-stage feasibility through clinical development and stability
• Partner closely with Formulation to advance the biopharmaceutical assessment strategy by investigating and characterizing in-vitro drug release, and predicting and correlating with in-vivo exposure
• Perform release and stability testing of drug product intermediates and finished products to ensure their suitability for preclinical or clinical studies according to cGDP and cGLP practices
• Collaborate with Manufacturing to troubleshoot and investigate issues arising during manufacturing campaigns through methodical and science-driven approaches
• Improve current analytical workflows by identifying and implementing innovative solutions that can increase efficiency and effectiveness from sample preparation to data analysis and reporting
• Compile, summarize and present key findings and analytical development strategies to cross-functional teams and company leadership
• Operate, maintain and troubleshoot laboratory equipment and instruments
• Author controlled documents including SOPs and regulatory filings

Qualifications

• Ph.D. in Analytical Chemistry, Polymer Chemistry, Pharmaceutical Sciences, or related field with 2+ years of relevant industry experience; Master’s degree with 5+ years of relevant industry experience; or Bachelor’s degree with 7+ years of relevant industry experience
• Experience developing methods based on various analytical techniques, including but not limited to HPLC, GPC, UV/Vis, fluorescence, thermal analysis, and software such as Empower, TRIOS, EcoSec, OMNIS
• Experience working in a GMP/GLP/GDP environment preferred
• Experience with managing vendors for analytical method transfers and instrument validation is a plus
• Experience working in small biotech or other highly collaborative, fast-paced environments