Sr Research Associate, Analytical Ops

Role Summary

Sr Research Associate, Analytical Ops supports analytical methods development and GMP testing for clinical and commercial drug substances and products. The role includes method validation and transfer, GMP data review, and regulatory data verification, with responsibilities spanning training QC analysts and escalating issues to management as needed.

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 Standard Operating Procedures (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.

Education

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

Skills

• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc.
• Excellent 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 in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance.
• Knowledge in Compliance System (e.g. GVault).
• Be an effective communicator of ideas and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience.
• Excellent verbal and written communication skills.