Senior Scientist, Physical Chemistry

Located at our large molecule headquarters in RTP, North Carolina, the Senior Scientist position will be the Subject MatterExpert (SME) for the physical chemistry team supporting CGT. This position is a team member in the Large Molecule &Advanced Therapy Medicinal Products Services (AMTP) in a Good Manufacturing Practices (GMP) laboratoryenvironment.ResponsibilitiesCritical Performance Areas: 1. Supervise, participate in lab activities and act as SME for physical chemistry assays.2. Collaborate with the team lead to train, develop, and coordinate daily laboratory tasks for the team.3. Develop, verify/validate, and transfer analytical methods for the analysis of drugs according to GMPrequirements.4. Generate, interpret data, and troubleshoot assays as needed.5. Handle multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients.6. Communicate effectively with clients providing scientific expertise to projects.Essential Job Functions: Ensure compliance with GMP regulatory requirements and SOPs.Review and approve lab notebooks, draft and review protocols and reports.Investigate under GMP for deviation, non-conformity, OOS, change controls, and other quality events.Train scientists and analysts in the team as needed.Contribute to process improvements for effective and efficient workflows in the lab.Maintain inventory, ordering of laboratory supplies, and instrument maintenance.Work collaboratively with cross-functional teams and customers.QualificationsM.S. or Ph.D. in Life Sciences with 5+ years relevant experience or B.A/B.S. with 10+ years relevant experience.Experience working in GMP or GLP environment.Strong experience in compendial qualification, validation/verification of methods using the following equipmentor techniques:o Osmolarity, Osmolality, Appearance Testing, and pH Measuremento HPLC (UV, FLD, RI, MS, ELS, DAD)o GC (FID, NPD, ECD, FPD, MS)o IRo UV/Viso Molecular weight distributiono Auto-titrationo Ion chromatographyo ICP-MSClient management experience is preferred.Other Desired Skills/Abilities:Excellent organizational skills, ability to work independently and collaboratively in a team environment.Strong written and verbal communication skills.Reporting StructureThis job typically reports to:Team Lead, Physical Chemistry