Director, Analytical Instruments

Gilead Sciences • Foster City, CA

9d • Onsite

About The Position

We are seeking a highly motivated individual to join the Internal Quality Strategy and Operations team. The successful candidate will lead instrument control and data acquisition management for complex analytical instruments supporting both small molecule and biologics within Quality Control. These capabilities include chromatography, microplate readers, mass spectrometry, endotoxin testing, titration, particle size analysis, Mettler-Toledo instrument data acquisition, x-ray diffraction, thermal analysis, nuclear magnetic resonance, and their associated instrument control and processing software. Generally complex instruments such as these are categorized as Group C instruments according to USP 1058, Analytical Instrument Qualification and used as a framework for establishing fitness for intended use. Candidate will lead a team that manages implementation, qualification, ongoing operations, enhancements, decommissioning, and retirement of these complex analytical instruments, their associated instrument control software and data following health authority regulatory compliance and data integrity requirements. The team is responsible for ensuring all changes are controlled and properly managed. Together the team supports the development and implementation of workflows to automate laboratory processes towards improved efficiency, compliance, and transform processes through innovative solutions. In addition, embracing emerging technologies including AI, and championing data-driven, digitally empowered ways of working is critical for success. This position reports to the Executive Director of Internal Quality Strategy and Operations and partners closely with Quality leadership, Technical Development, IT, Manufacturing, CMC Regulatory, Finance, Procurement, and the broader Gilead ecosystem. This role will sit in Foster City, CA.

Requirements

• Bachelor's Degree and Twelve Years’ Experience OR Masters' Degree and Ten Years’ Experience OR PhD and Eight Years’ Experience
• Understanding of USP 1058, Analytical Instrument Qualification and its application
• Responsible for Instrument control and data acquisition software such as Waters Empower, Mettler Toledo LabX, Softmax Pro, MassHunter, OMNIC Paradigm, OPUS, TRIOS, Tiamo
• Knowledge and expertise of various instrument and their software including chromatography, microplate readers, mass spectrometry, endotoxin testing, titration, particle size analysis, Mettler-Toledo instrument data acquisition, x-ray diffraction, thermal analysis, nuclear magnetic resonance, optical rotation, infrared spectroscopy, disintegration

Nice To Haves

• Hands-on laboratory experiences and analytical instrument use preferred.
• At least 5 years in leadership role managing teams across QC, lab operations, instrument and equipment management, informatics, data management
• Proven experience integrating instrument lifecycle, data and digital tools into workflows
• Established data acumen, understanding of advanced analytics, data management, data analysis
• Knowledge of data governance principles, systems integrations, and metadata management is a plus.
• Visionary leader who can define and execute a digital and data strategy for technical development
• Excellent collaborator with scientists, engineers, IT, manufacturing and others
• Change agent with the ability to inspire adoption and build digital fluency across teams
• Track record of building and managing high-performing, multidisciplinary teams
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Responsibilities

• Leadership and Management of Complex Analytical Instruments
• Maintain quality and compliance of instruments including data integrity, GMP adherence, and right-first-time execution
• Lead the business case development and ROI analysis for new complex instrument investments, effectively communicating trade-offs between speed, cost, and scope to leadership and stakeholders
• Deliver GMP analytical instruments and associated instrument control software to quality laboratories in a timely manner, with documentation, procedures, qualification, processes meeting their intended use
• Ensure instruments are highly available for testing to scientists and in a compliant state
• Foster relationships and work with major instrument and equipment vendors such as Waters, ThermoFisher, Agilent, Mettler Toledo
• Continuously refine quality operations strategy and roadmap aligned to organizational priorities and enterprise platforms
• Responsible for quality records associated with complex instrument deviations, change controls, corrective and preventative actions meeting closure timeline expectations and quality resolution
• Represent management and compliance of complex instruments during inspections
• Communicate to leadership, peers, laboratory community and stakeholders information such as utilization, reliability, maintenance, inventory, Innovation, Change Leadership, and Continuous Improvement
• Continually assess, review, analyze, and develop strategy and plans for complex analytical instrument management across Gilead internal laboratories. Look at process flow and efficiency such as flow, queue times, handoffs, and bottlenecks
• Leverage advanced analytics to transform the ways of working and drive data-centric solutions, and look for opportunities for the practical use of AI
• Engage with instrument vendors and industry to stay on top of emerging and next generation analytical instruments
• Partner with IT and Technical Development to identify, evaluate, and create strategic partnerships with established and emerging instrument technology providers to bring cutting-edge solutions and expertise into the organization
• Lead change management, including upskilling, communication planning, and user adoption. Partner with broader quality leadership and QC laboratory community to identify areas to remove friction or enable leapfrog innovation.
• Serve as a bridge between Internal Quality stakeholders, QC lab personnel, QA to enable product release, support filings, and stability programs. In addition, partners closely with Technical Development, IT, Manufacturing, CMC Regulatory, Finance, Procurement
• Foster relationships with internal partners (e.g., IT, CMC RA) and external vendors
• Represent Internal Quality in steering committees and structured content working groups. Align efforts with QC lab testing, drug development programs and instrument needs, data governance, instrument harmonization and standardization initiatives.
• Champion a safety mindset protecting employees, samples, and facilities
• Create a collaborative and inclusive work environment, promoting teamwork and effective communication
• Lead, mentor, and develop a high-performing team ensuring training, role clarity, engagement, and workload balance
• Implement visual management, KPIs, use proper escalation processes, and continuous improvement mindset

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director