Sr Research Associate, Analytical Ops

Job Responsibilities Conducts method validation and transfer experiments with limited guidance for clinical and commercial drug substances and products. Conducts GMP testing for release and stability of clinical drug substances and products using various analytical techniques. Applies knowledge and complies with GMP in daily activities. Conducts GMP data review to ensure compliance with applicable SOPs, test methods, specifications, and protocols. Performs regulatory filing analytical data verification to ensure data integrity. Conducts experiments for troubleshooting failures/investigations under supervision. Authors and reviews analytical test methods. Supports method transfer to qualify CMOs/CTLs for release and stability testing. Assists in training QC analysts. Escalates issues and risks to the manager and stakeholders, as applicable. Specific Education & Experience Requirements 2+ years of experience with a BA or BS degree in Chemistry or Biology. MS in Chemistry or Biology with 0+ industry experience. Knowledge and Skills Experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc. Technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments. Strong working knowledge of cGMP and quality control (QC). Knowledge of Lab information System and Part 11 software (e.g., Empower, Electronic Lab Notebook, SDMS, LIMS) for data integrity and compliant documentation. Knowledge of Compliance System (e.g., GVault). Effective communicator across cross-functional roles; proactively identify issues and develop solutions. Excellent interpersonal skills and verbal/written communication. Benefits Benefits include company-sponsored medical, dental, vision, and life insurance plans. #J-18808-Ljbffr Scorpion Therapeutics