Location: California, Foster City, USA
Company: Gilead Sciences
Job Position: Analytical Operations Research Scientist
JOB DESCRIPTION:
Qualification:
Education & Experience
PhD with 0+ years of industry experience (Post Doc in Chemistry Preferred), OR MS degree with 6+ years, OR BS degree with 8+ years of industry experience
- Strongest consideration will be given to candidates with demonstrated experience in parenteral drug product development (sterility, device and packaging, particulate matter, etc.)
- Proficiency or experience with one or more of the following analytical techniques: chromatographic separations (RPLC, SEC, Ion exchange, chiral), Mass spectrometry, parenteral characterization (osmolality, subvisible particles, pH, extractable volume, etc.), solid state characterization (particle size, XRPD, DSC/TGA, etc.)
- Excellent verbal communication and technical writing skills
Job Responsibility:
Develops analytical chemical test methods for small molecule parenteral/ injectable drug products (purity/impurity by LC, particulate matter, sterility, etc.)
- Develops physical characterization tests for drug substances for parenteral drug products (thermal analysis, particle size, microscopy, XRPD, etc.)
- Oversees design and execution of development, in-use, or accelerated stability studies
- Independently plans, executes, and troubleshoots experiments that support non-routine development activities and project goals
- Works cross-functionally with process chemistry, formulations development, method validation, release and stability groups, QA, and regulatory sciences to develop drug candidates
- May represent ACT at cross-functional meetings
- May lead operational aspects of a CMC project
- Provides guidance to junior team members on experimental design and data interpretation
- Develops subject matter expertise in an analytical technique and acts as a resource for other employees within the department
- Presents results of work, interprets data, and draws conclusions on complex problems using data from multiple sources
- Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects
- Authors reports, protocols, test methods, and other documentation
- May contribute to scientific literature and conferences or regulatory filings
- Must be flexible to support changes in project priorities and be able to adapt to fast paced working environment.
- Recommends alternatives, researches new methods and techniques, and may proactively seek out senior personnel to discuss potential solutions to problems
- Applies the principles and techniques of analytical chemistry to solving manufacturing and testing challenges