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Associate Scientist - Pivotal Biologics Commercial Analytical Development
Gilead Sciences - Oceanside, CA
posted 2 months ago
About the position
The Associate Scientist in Pivotal Biologics Commercial Analytical Development at Gilead Sciences plays a crucial role in executing laboratory techniques and supporting method development activities for biologics. This position involves collaboration with cross-functional teams, contributing to regulatory filings, and ensuring the successful commercialization of analytical methods. The role requires a strong understanding of analytical life cycle concepts and the ability to communicate findings effectively.
Responsibilities
- Proficiently execute laboratory techniques such as HPLC/UPLC, CE-SDS, cIEF, LC-MS, and other techniques commonly used for biologics.
- Present findings to cross-functional internal/external teams.
- Author analytical test methods, study protocols, and technical reports.
- Contribute to regulatory filings.
- Act as analytical method owner for assigned assays by developing a deep understanding of method attributes and performance through execution and/or review of robustness experiments and method monitoring in preparation for commercialization.
- Contribute to late-stage method validation activities internally and at external laboratories.
- Independently plan and execute assigned experiments to support method development activities and non-routine investigations to deliver on project goals.
Requirements
- MS degree with 3+ years relevant industry experience or BS degree with 5+ years relevant industry experience.
- Excellent technical communication skills, both verbal and written.
- Understanding of analytical life cycle concepts as applied to analytical development.
- Familiarity with FDA and ICH guidelines relating to analytical procedure development and validation.
- Demonstrated skills in analytical instrumentation and data analysis (e.g., HPLC, CE, cIEF).
- Critical and creative thinking skills, with the ability to determine appropriate resources for problem resolution and strong organizational and planning skills.
Benefits
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
