Research Scientist, Analytical OperationsUnited States - California - Foster CityProcess/Product Development & OperationsRegular
- Manages method development, validation and transfer, release testing, and stability testing from early to late stage development and commercial products for manufactured Gilead products (drug substance and drug product)
- Manages multiple projects, works closely with internal customers, CMOs and external vendors/contractors to ensure analytical deliverables are met per the project timelines
- Participates in or leads cross-functional project teams.
- Provides the highest quality analytical support, meets aggressive timelines while ensuring compliance to SOPs, protocols, cGMPs and safety regulations
- Supports local and global regulatory filings regarding analytical method validation and method transfer
- Coordinates activities for members of project teams in the initiation and execution of laboratory experimentation.
- Plans, designs and implements laboratory experimentation for method validation and method transfer.
- Works on a wide range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
- Oversees review of data from contract laboratories. Leads on-site data-based review of contract partners at specified frequency and verify data integrity and technical appropriateness. Serves as a key member of the Gilead team in the contract lab qualification and requalification process
- Serves as a resource to management on the operational strategy of the research function and provides long term resource planning for equipment, laboratory space and staffing levels.
- Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
- Applies the principles and techniques of Analytical Chemistry to products and problems.
- Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize substances, assays and tools.
- Working under general supervision, plans, designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug substances or techniques to identify such substances.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
- Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- May make contributions to scientific literature and conferences or regulatory filings.
Essential Education, Experience & Skills:
- PhD in pharmaceutical sciences, analytical or physical chemistry, materials science, or engineering and 0+ years of experience, OR an MS degree with 6+, OR a BS degree with 8+ years of experience. Post Doc & industry experience strongly preferred.
- Excellent scientific and business communication skills (both verbal and technical) are required
- Excellent interpersonal skills are required
- Demonstrates strong leadership skills
- Demonstrates high level of proficiency and responsibility
- Strong consideration will be given to candidates with demonstrated expertise in parenteral and inhalation product development, and/or dissolution method development.
- Has a strong grasp of the underlying science but able to take on additional operational responsibilities because of talent and indicated interest