Director, Quality Control Biologics (Analytical Lifecycle Management)

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
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.  

Analytical Lifecycle Management: 

The Director Analytical Lifecycle Management is vital for the success of Clinical Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include managing Clinical specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program.

The role is accountable for monitoring QC test method execution and leading the analytical lifecycle management of Clinical biologics drug substances and drug products. The Director collaborates with cross-functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and regulatory compliance. 

Department:  

Global Quality Control – GQC-Biologics  

Job Responsibilities:

• Oversee the development and implementation of end-to-end Specification strategy for Gilead’s portfolio of biologics products. 

• Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead. 

• Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met. 

• Provide oversight and management of Biologics Reference Standards and Critical Reagents. 

• Demonstrate a clear understanding of biological product testing methods and assays for effective QC test method execution, troubleshooting, and remediation of atypical results. 

• Identify, select, manage, and evaluate CMOs/CTLs, consultants etc. to control quality in support of achieving PDM’s strategic objectives. Establish clear expectations, metrics and KPIs, as appropriate to monitor analytical method performance. 

• Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across external network partners. Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control. 

• Support validation of analytical methods for new Biologics programs and their transfer to outsourced partners to meet GMP testing needs. 

• Lead the Compendial Review Program, leveraging existing Gilead Quality Control Systems. 

• Lead or serve as a key project team member on large cross functional projects, often with high visibility to senior management within the organization or with international impact. 

• Provide a long-term view to senior QC Leadership based on personal knowledge of the competitive environment. 

• Interface with Regulatory agencies as required representing