Senior Associate Scientist, Analytical Operations

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.

We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.

Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite.

As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.

Join Gilead and help create possible, together.

Job Description

Specific Job Responsibilities

The incumbent is responsible for analytical support of Gilead commercial products . Accountabilities cover small molecule drug substance and drug product including release, stability, investigations, change control and analytical method life cycle management as detailed below :

• Represent Global Quality Control in the CMC team for assigned commercial products as an analytical operations lead (AOL), provide analytical support for drug substance and drug product, release and stability, manage life cycle of commercial products, such as, product line extension, shelf-life / retest period, revision of procedure and specification
• Accountable to oversee a variety of studies, trend stability data, prepare, review and approve necessary reports. Provide scientifically sound and data-based support of product investigations, impact assessments, and other change controls
• Work with internal and contract organizations to conduct laboratory investigations as needed to ensure investigations are closed in a timely and compliant manner
• Provide support to fulfill regulatory commitments and to address regulatory related inquiries for commercial products, including updated stability summary reports for annual report and other required documentation
• Support routine commercial manufacturing related activities including review and approve release data, participate in audits as needed, and provide support for inspection needs at Gilead and contract sites as required

Essential Duties and Job Functions :

• Effective communication with both external contract partner and internal cross-functional teams to meet Gilead business objectives
• Ability to clearly define objectives and bring issues to timely resolution
• Work with Regulatory & Quality Assurance to ensure that all applicable FDA regulations are followed and properly documented
• Responsible for managing assigned products; well experienced with Empower, LIMS, change control as well as other documentation systems
• Manage and evaluate laboratory deviation and investigation incidences and determine need for escalation
• Prioritize projects and determine resource constraints as needed
• Perform investigations as required to support commercial products
• Serve as the technical and operational resource for the stability related activities
• Interface with other PDM functions on project strategy
• Apply current Good Manufacturing Processes (cGMPs) and Good Laboratory Practices (GLPs) concepts daily
• Review test data and results to ensure compliance with appropriate specifications and protocols
• Lead or participate in group meetings, present data, and prepare information for others to present
• Ability to use statistically based software to perform data trend analysis and assist in investigations.
• Use Microsoft Office software applications to write, revise, and execute protocols, methods, specifications, Standard Operating Procedures (SOPs), and reports
• 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

Knowledge, Experience & Skills

Past experience in quality control and analytical development, working with CMOs and testing labs, method development / validation, QC / stability support, conducting investigation, trouble shooting, and regulatory CMC support is preferred

Minimum Qualifications :

• 6 + years of experience with BA or BS degree in chemistry or Biology
• 4 + years of experience with MS degree in chemistry or Biology

The salary range for this position is : $133,280.00 - $172,480.00. 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*.