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.
