Vertex is seeking a talented scientist to join our small molecules Analytical Development group in San Diego, CA. This individual will play a central role in advancing transformative medicines by leading analytical chemistry activities for small molecule development programs from preclinical through to Phase 1. This role includes representing Analytical Development at cross-functional project team meetings and so demonstrable experience to resolve project challenges in collaboration with other R&D functions is required. The ability to work both independently and in a matrix team environment is essential to succeed in this position. The role also includes the responsibility of overseeing and performing multiple types of mass spectrometry analysis. Key Duties and Responsibilities: Project oversight: represent Analytical Development at cross functional teams and effectively communicates issues and solutions to colleagues at all levels within the organization. Strategy: develop, align and execute analytical project team plans and strategies to support drug substance and drug product development including methods development, stability and validation activities. Laboratory expertise: apply advanced analytical skills and understanding in laboratory techniques routinely used in the analysis of drug substance and drug product samples. Mass spectrometric expertise: Performs high resolution mass spectrometry analysis for proof of structure and elucidation of impurities. Maintains MS instrumentation and troubleshoots issues as required. Develops and validates ppm-level trace analysis methods, performs isotopic purity and high-resolution mass analysis. Collaboration: work both independently and collaboratively within a matrix team environment. Communication: demonstrated ability to effectively present results in both oral and written reports and to productively disseminate ideas across discipline and project boundaries. Advanced strategic initiatives: develop, contribute and support new ways of working, operating models and paradigms that improve productivity, efficiency and overall effectiveness of workflows and processes. Knowledge and skills: Experienced Analytical Lead (pre-clinical to Phase 1) in the pharmaceutical or biotechnology industry. The ability to work successfully in both a team/matrix environment as well as independently. In-depth expertise of mass spectrometry including theory, practice, and troubleshooting. Proficient in operating high-resolution accurate mass MS systems for structural elucidation and characterizations of impurities present in drug substances. Strong understanding of organic reactions and mechanisms. Technical expertise in analytical techniques that include LC, GC, KF, NMR, XRF etc. Advanced troubleshooting skills and problem-solving capabilities. Strong analytical data assessment, review and interpretation skills. Advanced experience in communication of technical data: writing reports and presentation skills. High attention to detail. Ability to work in a fast-paced environment, managing priorities and maintaining timelines. Strong knowledge of cGMPs and pharmaceutically relevant regulatory guidelines. Education and experience: Ph.D. with 4-7 years, Master’s degree with 7+ years, or Bachelors degree with 10+ years of relevant professional analytical development experience in the pharmaceutical industry.
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