Analytical Scientist III

Responsibilities

Include but are not limited to the following:

• Define and implement analytical strategies for new product development and lifecyle management.
• Serve as a senior technical leader and subject matter expert for analytical technologies.
• Lead cross-functional initiatives to optimize analytical processes and ensure regulatory compliance.
• Perform analytical method development and technology transfer including method verification and method validation to support product development and regulatory applications
• Read and interpret analytical methodology and USP monographs.
• Provide analytical data packages for regulatory filings (FDA, EMA)
• Operate UPLC/HPLC/GC as well as other analytical instruments and perform troubleshooting and calibration as needed.
• Perform analytical testing of pharmaceutical drug products and/or raw materials following analytical methodology while adhering to internal and external customer requirements and schedules.
• Collaborate with product developers and engineers to create or optimize chemistry of active formulations
• Develops and conducts studies that are in compliance with applicable regulations and SOPs
• Maintain lab and laboratory equipment according to manufacture's specifications
• Point of contact with contract laboratories and vendors for specific projects regarding, technical transfers, investigations, and development
• Developing and optimizing analytical assays in collaboration with instrument manufacturers.
• Write laboratory related documents including protocols, reports, and/or methods and evaluate records for high accuracy.
• Assist in the development of laboratory expertise in analytical technologies to increase the capability to support internal and external customers for future requirements.
• Other duties as assigned

Qualifications/Education/Special Skills

• Masters - 3+ years, BS - 5+ years of relevant industry experience. Degree in Analytical Chemistry, Pharmaceutical Sciences, Engineering or a similar applicable field
• Experience in analytical method development, validation, and regulatory submission support.
• Experience in UPLC/HPLC/GC-MS QTOF and other spectroscopic instruments.
• Expertise in analytical method verification/validation and technology transfer activities including technical writing and cleaning validation.
• Ability to perform calibrations and troubleshoot analytical instrumentation as needed.
• Strong knowledge in USP, ICH, cGMP, and cGLP requirements.
• Excellent technical writing, communication and project management skills
• Ability to lead multiple studies and influence technical direction across R&D
• Proficiency in statistical analysis and laboratory software applications.