Analytical Chemist

Essential Duties & Responsibilities

• Lead analytical method development, validation and transfer for drug eluting medical device. Primary assays will be HPLC, mass spectrum, and in vitro drug release (e.g. USP <1092>, USP <724>).
• Lead the development, validation and implementation of appropriate pharmaceutical analytical methods at CDMOs and CROs in support of drug-eluting device in development and clinical programs, with focus on analytical methods for release testing and stability, in process controls/tests, impurity controls, and ongoing API and drug product characterization as needed.
• Develop and lead internal analytical team to perform tests supporting product development, preclinical, clinical studies and product release.
• Analyze results, solve analytical issues, and meet regulatory expectations for analytics applied to drug products.
• Review analytical instrument and equipment calibration, qualification and maintenance record`s.
• Author, review and approve analytical documents such as analytical method development protocols and reports, feasibility study protocols and reports, qualification protocols, validation protocols, transfer protocols, validation reports, methods of analysis, and laboratory investigation reports.

Education & Experience: 

• PhD in chemistry, analytical sciences or pharmaceutical science with a minimum of 6 years of experience.
• BS or MS in chemistry, analytical sciences or pharmaceutical science with a minimum of 12 years of experience.
• At least 10 years of related pharmaceutical development and analytic development experience with focus on small molecules. Experience with drug-eluting medical device is highly preferred.
• BS in a scientific discipline required.  MS preferred.
• Expertise in chromatographic (HPLC, UPLC, GC) and spectroscopic (MS, UV/Vis), and other analytical techniques is required.
• In-depth working knowledge of pharmaceutical analytical techniques, analytical method development, method transfer, method validation and stability.
• In-depth working knowledge of ICH guidelines and FDA Guidance related to Pharmaceutical development, validation, manufacturing and stability of drug substance and drug product.
• Experience in regulatory filings (CDER, CDRH), specifications and controls, analytical method development and validation and the commercialization process. Experience with PMA submission for combination product is a plus.
• Proven leadership skills with experience in building and managing multidisciplinary teams and ability to drive results. Experience in effectively managing external labs and contractors to optimize development.