Early stage medical device company is searching for a qualified, highly motivated analytical chemist to join our analytical team. Our mission is to develop a revolutionary new technology that will transform the urology market through better patient outcomes. This position reports directly to the Analytical Manager.
• Develop and validate analytical methods using HPLC, FTIR, dissolution apparatus, and other analytical instrumentation.
• Conduct routine analyses and data process using analytical instruments such as HPLC and dissolution apparatus.
• Maintain and troubleshoot analytical instruments
• Communicate technical results and observations to the team
• Write plans, protocols, and reports to support regulatory filings
• Support operations to bring device to commercialization
• Think creatively, problem solve, and develop innovative solutions based on sound scientific analysis
• Other duties as required in small company
• Four-year degree in Chemistry or Chemical Engineering with emphasis in analytical techniques or
related field with 0-3 years of hands-on experience using analytical instruments and conducting analysis.
• Understanding of pharmaceutical regulations and medical device regulations and standards
• Understanding of quality systems and change control
• Knowledge of Chromeleon (or equivalent) HPLC analysis software
• Ability to execute controlled experiments with a strong attention to detail is essential
• Driven self-starter with capability to work independently as well as with a small work place team
• Comfortable working on high risk technologies in a fast paced, high pressure start-up environment
• Great computer skills including MS Office and statistical analysis software
• Excellent oral and written communication skills