Sr Scientist, Analytical Development

The Senior Scientist, Analytical Development will be responsible for developing analytical techniques to support drug substance and drug product formulation development activities. 

Responsibilities:

• Develop analytical techniques to support drug substance process and drug product formulation development activities
• Manage analytical method development to support characterization of drug substance and drug products
• Apply scientific principles in selecting appropriate techniques for development of sensitive and robust methods
• Troubleshoot analytical methods, hardware and software issues arising at CROs/CMOs
• Research new techniques and recommend alternative approaches and potential solutions to analytical issues
• Write analytical test methods, protocols and reports as part of analytical transfers to CROs/CMOs for GMP testing
• Contribute to authoring of CMC sections to support regulatory filings
• Serve as an analytical subject matter expert within department and cross-functional areas

Qualifications:

• Ph.D in analytical chemistry or related disciplines, with at least 5 years relevant experience in pharmaceutical industry

Skills, Knowledge & Abilities:

• Extensive knowledge and hands-on experience on chromatographic and spectroscopic techniques (e.g. GC, HPLC, MS, UV/Vis)
• Knowledge of techniques required for physicochemical characterization of drug substance (e.g., particle size, TGA, DVS, DSC etc.)
• Experience with analytical method validations and transfers in regulated environments is required
• Experience with development and validation of methods for bioassay to determine potency is a plus
• Attention to detail and excellent analytical skills as applied to data review and investigations
• Passion for learning, creating, relating, communicating, and leading cross functional teams
• Excellent verbal and written communication skills
• Experience in a start-up environment preferred
• Must be pro-active team player, flexible, and open to change