Sr Research Associate, Analytical Ops
Gilead Sciences
5 months ago
On-site
San Francisco Bay Area
Operations
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 (as stated):
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions:
- Please apply via the Internal Career Opportunities portal in Workday.
- 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 (as stated):
- Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Application Instructions:
- Please apply via the Internal Career Opportunities portal in Workday.