Senior Scientist I, Analytical Chemistry

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the KindevaPurpose-driven work environmentSignificant growth potentialCollaborative team cultureDirect impact on patient careIndustry-leading innovationThe Impact You Will MakeTransform Lives Through Scientific InnovationJoin a growing pharmaceutical CDMO where your expertise will directly support the development of innovative drug products that improve patient health a Senior Scientist Analytical Chemistry you will serve as a technical leader within the R&D Analytical Chemistry group leading analytical strategies that support pharmaceutical product development from early-stage development through commercialization. You will provide scientific leadership in method development validation verification transfer and troubleshooting activities while partnering with cross-functional teams to advance customer programs and internal development role is ideal for a scientist who thrives in a fast-paced development environment enjoys solving complex technical challenges and is passionate about mentoring others while advancing analytical capabilities within a growing OpportunityOur Lexington site continues to experience significant growth across development and manufacturing programs. This position offers the opportunity to lead complex analytical projects support innovative drug development programs influence technical strategy mentor junior scientists and expand Kindevas analytical capabilities while working closely with customers and internal development Method Development & ValidationLead the development optimization and validation of robust analytical methods for drug substances and drug products in accordance with ICH USP and regulatory and execute complex analytical studies to support formulation development process development stability programs and customer or support technology transfer of analytical methods to internal and external QC laboratories and qualification of new analytical laboratory new analytical techniques and instrumentation to expand internal as a subject matter expert (SME) for analytical technologies method troubleshooting and regulatory Leadership & Technical ExecutionProvide leadership and execution of complex scientific creative thinking to generate solutions to complex technical personal workload to ensure key objectives are achieved on time and within project current with advancements in analytical technologies industry best practices and regulatory and provide technical oversight to junior scientists and analysts ensuring scientific rigor and compliance with quality Compliance & Regulatory SupportAuthor and review technical documents including method validation protocols and reports specifications analytical development reports and regulatory submissions (IND NDA ANDA BLA).Prepare and maintain accurate and timely laboratory records in accordance with company policies and regulatory compliance with GMP requirements regulatory expectations and internal quality regulatory inspections customer audits and compliance initiatives as -Functional Collaboration & Business SupportCollaborate cross-functionally with Formulation Development Process Development Quality Assurance Regulatory Affairs Manufacturing and customer teams to ensure successful product Analytical Chemistry in project meetings and customer meetings with limited to continuous improvement initiatives and innovation within the analytical development Marketing and Business Development activities through technical presentations posters publications blogs white papers and industry cross-functional training and execution of activities within the R&D Product Development & Design Team as in a scientific discipline with 1 years of relevant experience; Masters degree with 3 years of experience; Bachelors degree with 6 years of experience; or 9 years of equivalent experience without a -depth experience with analytical techniques including HPLC UPLC GC UV FTIR spray testing compendial methods and related analytical success in analytical method development optimization validation and troubleshooting under GMP and ICH understanding of regulatory requirements and CMC components of pharmaceutical drug with stability testing impurity/degradant characterization and forced degradation ability to lead technical projects and work effectively within cross-functional written and verbal communication skills including experience authoring technical and regulatory ability to mentor influence and develop junior scientists and technical with nasal spray drug products and device-related analytical testing is within pharmaceutical biotechnology contract development and manufacturing (CDMO) or regulated product development environments strongly Demands / QualificationsEmployee is required to regularly use hands in order to handle laboratory materials and is required to use computers for extended periods each is required to effectively communicate through both verbal and electronic is required to regularly stand and walk for extended periods of must occasionally lift and/or move up to 25 to use proper lifting techniques and remain aware of laboratory and workplace is required to follow all site safety procedures and wear appropriate our One Team mission of manufacturing more tomorrows. Your scientific expertise will help advance innovative therapies and improve the health and well-being of patients around the world.#LI-Onsite