Research Scientist, Analytical Operations (Quality Control)米国 - カリフォルニア - オセアニア製品開発・オペレーション正社員
Research Scientist, Analytical Operations (Quality Control)
With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Serves as SME for chemical/biochemical method validation. Leads development of stage-appropriate validation strategy from Phase 1 clinical development through commercial manufacturing.
Plans, designs, and manages method validation activities in Gilead QC and at contract laboratories.
Coordinates GMP testing in Gilead QC laboratory and leads CAPA activities as necessary.
Oversees review of analytical data from Gilead QC and contract laboratories.
Manages multiple projects; working closely with internal customers, CMOs, and external vendors/contractors to ensure analytical deliverables are met per the project timelines.
Utilizes organizational and planning skills to understand resource capabilities. Negotiates timelines and deliverables based on priorities and resource availability.
Provides high-quality analytical support while meeting aggressive timelines and ensuring compliance to SOPs, protocols, cGMPs, and safety regulations.
Manages 2-3 direct reports with responsibilities in method validation, GMP testing, and process development testing.
Contributes to project teams by communicating strategies and providing timely progress reports.
Supports local and global regulatory filings by authoring and/or reviewing relevant analytical sections.
Participates in or leads cross-functional project teams.
Thinks critically and creatively and proactively identifies improvement opportunities.
Essential Education, Experience & Skills
Ph.D. with 4+ years of relevant experience, or MS with 6+ years of relevant experience, or BS with 8+ years of relevant experience.
Extensive experience in a GMP-regulated laboratory with in-depth knowledge of QC principles, concepts, and industry practices is essential.
Hands-on experience leading product-specific method validation and compendial method verification is required.
Excellent communication and leadership skills are required.
People management experience required.
Keen understanding of international quality control systems regulations to adopt best-in-class systems/processes and drive continuous improvement initiatives.
Preference given to candidates with technical experience in methods used for biologics and parenteral drugs.