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.

• 2+ years of experience with a BA or BS degree in Chemistry or Biology.
• MS in Chemistry or Biology with 0+ industry experience.

• 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 include company-sponsored medical, dental, vision, and life insurance plans.