Director, Analytical Instruments

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

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 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.

Key Responsibilities:

Leadership and Management of Complex Analytical Instruments

• 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

• 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

• 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

• Critical thinking and analysis of overall instrument landscape processes metrics pain points and opportunities for improvement GMP Compliance Program Delivery Vendor Coordination Always Inspection Ready

• 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.

Collaboration and Influence

• Serve as a bridge between Internal Quality stakeholders QC lab personnel QA to enable product release support filings and stability 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.

Leadership & People Development:

• 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

Basic Qualifications:

Bachelors Degree and Twelve Years Experience

OR

Masters Degree and Ten Years Experience

OR

PhD and Eight Years Experience

Preferred Qualifications:

• 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

Technical & Strategic Skills:

• Demonstrated enterprise mindset with ability to align Quality needs to enterprise platforms and solutions ensuring scalability interoperability and long-term business value.

• Proven success leading instrument initiatives from strategy through implementation.

• Established data acumen understanding of advanced analytics data management data analysis

• Knowledge of data governance principles systems integrations and metadata management is a plus.

Leadership & Soft Skills:

• 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

People Leader Accountabilities:

• 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.

For additional benefits information visit:

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

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.