Sr Research Associate, Analytical Ops
Gilead Sciences
3 hours ago
On-site
San Francisco Bay Area
Operations
Job Responsibilities:
- Conduct method validation and transfer experiments with limited guidance for clinical and commercial drug substances and products.
- Conduct GMP testing for release and stability of clinical drug substances and products using various analytical techniques.
- Apply knowledge and comply with GMP in daily activities.
- Conduct GMP data review to ensure compliance with applicable SOPs, test methods, specifications, and protocols.
- Perform regulatory filing analytical data verification to ensure data integrity.
- Conduct experiments for troubleshooting failures/investigations under supervision.
- Author and review analytical test methods.
- Support method transfer to qualify CMOs/CTLs for release and stability testing.
- Assist in training QC analysts.
- Escalate issues and risks to the manager and stakeholders, as applicable.
Education & Experience Requirements:
- 2+ years of experience with a BA or BS in Chemistry or Biology.
- MS in Chemistry or Biology with 0+ industry experience.
Knowledge and Skills:
- Experience conducting/analyzing data for analytical methods (e.g., UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution).
- Technical and laboratory skills to execute analyses efficiently in GMP-regulated environments.
- Strong working knowledge of cGMP and QC.
- Knowledge of Lab Information Systems and Part 11 software (e.g., Empower, ELN, SDMS, LIMS) for data integrity and compliant documentation.
- Knowledge of Compliance System (e.g., GVault).
- Effective communication across cross-functional teams; proactively identify issues and develop solutions.
- Strong interpersonal, verbal, and written communication skills.
Compensation & Benefits (if eligible):
- Salary range: $94,945.00 - $122,870.00; may include discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions:
- For current employees/contractors: Apply via the Internal Career Opportunities portal in Workday.
- Conduct method validation and transfer experiments with limited guidance for clinical and commercial drug substances and products.
- Conduct GMP testing for release and stability of clinical drug substances and products using various analytical techniques.
- Apply knowledge and comply with GMP in daily activities.
- Conduct GMP data review to ensure compliance with applicable SOPs, test methods, specifications, and protocols.
- Perform regulatory filing analytical data verification to ensure data integrity.
- Conduct experiments for troubleshooting failures/investigations under supervision.
- Author and review analytical test methods.
- Support method transfer to qualify CMOs/CTLs for release and stability testing.
- Assist in training QC analysts.
- Escalate issues and risks to the manager and stakeholders, as applicable.
Education & Experience Requirements:
- 2+ years of experience with a BA or BS in Chemistry or Biology.
- MS in Chemistry or Biology with 0+ industry experience.
Knowledge and Skills:
- Experience conducting/analyzing data for analytical methods (e.g., UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution).
- Technical and laboratory skills to execute analyses efficiently in GMP-regulated environments.
- Strong working knowledge of cGMP and QC.
- Knowledge of Lab Information Systems and Part 11 software (e.g., Empower, ELN, SDMS, LIMS) for data integrity and compliant documentation.
- Knowledge of Compliance System (e.g., GVault).
- Effective communication across cross-functional teams; proactively identify issues and develop solutions.
- Strong interpersonal, verbal, and written communication skills.
Compensation & Benefits (if eligible):
- Salary range: $94,945.00 - $122,870.00; may include discretionary bonus, stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.
Application Instructions:
- For current employees/contractors: Apply via the Internal Career Opportunities portal in Workday.