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Associate Scientist – Pivotal Biologics / Analytical Operations
| Company | Gilead Sciences |
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| Location | Oceanside, CA, USA |
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| Salary | $99705 – $129030 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Junior, Mid Level |
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Requirements
- MS degree with at least 2 years of relevant industry experience or BS degree with at least 4 years relevant industry experience
- Excellent technical communication skills, both verbal and written
- Understands the analytical life cycle concepts as applied to analytical development
- Familiar 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)
- Must think critically and creatively, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
Responsibilities
- Proficiently executes 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.
- Authors analytical test methods, study protocols, and technical reports. Contributes 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.
- Contributes to late-stage method validation activities internally and at external laboratories.
- Independently plans and executes assigned experiments to support method development activities and non-routine investigations to deliver on project goals.
Preferred Qualifications
No preferred qualifications provided.
