Director, Analytical Instruments

Overview

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 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. The 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.

• 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, Mass Hunter, 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…