Associate Scientist, Analytical Outsourcing

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

• Executes and ensures compliance to procedures for outsourced testing oversight
• Manages outsourced analytical and quality control testing activities for small molecule APIs and drug products, or biologics bulk drug substance, drug products, and parenterals
• Establishes priorities and coordinates testing schedules based on program requirements by interfacing with colleagues in Technical Development and Manufacturing Operations
• Represents Gilead Analytical Function in Quality audits and Business Review meetings at contract partners
• Reviews and facilitates approval of proposals, work orders, changes of scope, and invoices
• Develops metric parameters to evaluate and monitor the performance of contract service providers
• Provides necessary support during regulatory inspections of Gilead or at contract partner sites for Gilead drug substance and drug product
• Executes strategies that drive effective operational performance and service levels at contract organizations
• Maintains detailed knowledge and information regarding contract partner services, capabilities and processes
• Provides input for budgeting based on outsourced analytical needs
• Communicates risks and delays to management and technical leads on a timely basis
• Supports strategic business and quality compliance processes and changes by participating in working groups and acting as business process owner for system changes as needed
• Coordinates with legal and quality assurance groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements
• Serves as the Analytical Functional Site Lead for one or more contract testing partners, responsible for managing the business relationship and day to day activities
• Assists in transfer of new projects to various contract organizations

• Strong communication skills, both verbal and written, with all levels of an organization
• Proven ability to problem solve, build strong relationships, and to organize effectively
• Prior experience with analytical/QC testing for solid oral dosage forms and/or parenteral, or large molecules/biologics is preferred.
• Demonstrated ability to multi-task
• Ability to influence and work well with others in a proactive and constructive manner
• Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
• An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements

• 8+ years of experience with a BA or BS degree in Analytical Chemistry or other relevant area of science; or 6+ years of experience with MS degree in Chemistry or Biology
• Direct experience managing supplier relationships and outsourced analytical/QC testing highly desirable

The salary range for this position is: $101,830.00 - $131,780.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.