Exec Director, Analytical Operations

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
 

Responsibilities

• Lead and manage a team responsible for creating and executing analytical technology roadmaps to support advanced manufacturing initiatives including continuous manufacturing and real-time release testing. This encompasses the development of online and inline analytical technologies, innovative Process Analytical Technologies (PAT), increased automation, miniaturization, applications of artificial intelligence and machine learning (AI/ML), as well as rapid microbiological testing.

• Leverage existing and novel analytical technologies to harmonize end-to-end analytical control strategies of all Gilead therapeutic modalities in close partnership with Technical Development, Quality, Regulatory, and Manufacturing teams.

• Develop approaches and tools that connect product quality and stability with variations in raw materials, process conditions, and data from product characterization.

• Collaborate with stakeholders to evaluate how new analytical technologies affect pipeline progress, comparability strategies, and investigations.

• Oversee analytical lab automation, high-throughput analysis, and AI/ML initiatives to enhance productivity, and evaluate advanced technologies for implementation in GMP routine quality control testing.

• Deliver strategic leadership in establishing an external innovation network by facilitating collaborations with leading academic institutions and industry vendors. Evaluate the feasibility of emerging analytical technologies and guide their development to ensure successful integration in all Gilead therapeutic modalities

• Collaborate with internal teams such as Technical Development, Regulatory, Quality, and Manufacturing, as well as external partners like peer biopharma companies and vendors, to secure global health authority approval for innovative analytical methods. This includes working closely with CMC Regulatory Affairs to proactively develop strategies for engaging regulatory agencies regarding new analytical technologies, such as through FDA’s Emerging Technology Team (ETT), etc.

• Influence senior leadership and stakeholders by communicating analytical advances and representing the company at scientific forums, regulatory meetings and industry consortia to actively contribute to the development of future global regulatory standards.

Qualifications

• Ph.D. Degree in Analytical Chemistry, Pharmaceutical Science, Chemical Engineering, or equivalent with 14+ years of experience in CMC development of small molecule and/or biologic products.

• Externally recognized as an industry expert and thought leader in a related analytical discipline with proven record of enabling and implementing new technologies.

• Extensive experience influencing effectively within a matrix organization.

• Demonstrated expertise in data sciences, process analytical technology (PAT), chemometrics, and automation.

• Proficient in AI/ML applications within the pharmaceutical sector.

• Balance adopting new technology with maintaining data utility.

• Influence senior leadership and stakeholders by communicating analytical advances and representing the company at scientific forums, regulatory meetings and industry consortia to actively contribute to the development of future global regulatory standards.

• Proven ability to lead organizational change initiatives successfully.

• Substantial experience preparing regulatory submissions an