Research Scientist, Analytical Operations

Job Description

Job Responsibilities:

• 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