Director, Analytical Instruments

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.
 

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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 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.

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 pr