Senior Scientist I, Analytical Chemistry

Purpose The Product Development Science and Technology (PDS&T) Analytical organization is currently seeking a Senior Scientist to join our team. As a Senior Scientist, you will have the opportunity to independently develop and execute analytical methods to support robust manufacturing processes development for clinical phase and commercial products. You will play a crucial role in ensuring the quality and efficacy of our products, making a direct impact on patient health and well-being. This position involves highly collaborative work where you will have the chance to work closely with cross-functional teams including process and product development, CMC, process engineering, internal and external manufacturing, quality assurance, supply chain, and Operations Manufacturing Sites. This collaborative environment will allow you to expand your knowledge and skills while making meaningful contributions to our organization.   Responsibilities:  • Responsible for method development, testing procedures, and implementation of analytical control strategies to help the advancement of pipeline candidates.  • Leads the analytical aspects of a project including method development and validation, control strategy development, specification justification, data generation, regulatory submissions, technology transfer, and investigations.   • Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical products to further the understanding of emerging cGMP manufacturing processes.  • Utilize understanding of a range of analytical techniques to conduct research and development studies related to synthetic molecule drug products, active pharmaceutical ingredients, intermediates, starting materials, impurities and impurity profiling.  • Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data in support regulatory requirements.  • Highly autonomous in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.  • Formulate conclusions and design follow-on experiments based on multidisciplinary data.  • May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a development program.  • Process, interpret, and visualize data to facilitate project team decisions.  • Communicate and collaborate with cross-functional groups and departments.  • Routinely demonstrate scientific initiative and creativity in development activities and maintain a high level of productivity in the lab.  • Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.  • Ph.D. in Analytical Chemistry with 0 to 4 years of related industry experience highly preferred. Advanced degree in Analytical Chemistry preferred.  • Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary. • Understanding of cGMP and current regulatory requirements highly preferred.  • Practical knowledge of organic structures, chemical reactions, functional groups, and modern spectroscopic techniques as applied to small-molecule analytical analysis preferred.  • Strong chromatography knowledge and proven ability to independently develop, troubleshoot, and improve methods.  • Hands on experience with HPLC/GC analysis and method development along with expertise and fundamental understanding of spectroscopic techniques.  • Self-motivated, hard-working, detail-oriented individual able