Director Quality Control Biologics Analytical Lifecycle Management

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 lifechanging 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

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 lifethreatening 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 and leading the analytical lifecycle management of Clinical biologics drug substances and drug products. The Director collaborates with crossfunctional 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 GQCBiologics

Job Responsibilities:

• Oversee the development and implementation of endtoend Specification strategy for Gileads 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 troubleshooting and remediation of atypical results.

• Identify select manage and evaluate CMOs/CTLs consultants etc. to control quality in support of achieving PDMs 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 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 longterm view to senior QC Leadership based on personal knowledge of the competitive environment.

• Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to GxP.

• Willing to support future laboratory work.

• Willing to support Commercial QC team.

Qualifications:

• 12 Years experiences with BS OR

• 10 Years with MS OR

• 8 Years with PhD in Chemistry Biochemistry or related field.

• 2 year of relevant experience in a GMP Lab environment including knowledge of analytical testing familiarity with laboratory instrumentation.

• Must have experience with GMP systems e.g. LIMS QMS SAP) and software such as Empower JMP Discoverant.

• Preferred experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry.

• Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

• Strong organizational and planning skills.

• Shows excellent verbal and written communication skills and collaborative interpersonal skills.

For additional benefits information visit:

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

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