Senior QC Scientist, Biologics Quality Control (Analytical Lifecycle Management)

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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.
 

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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.

Senior QC Scientist , Biologics Quality Control - Analytical Lifecycle Management team.

Analytical Lifecycle Management:

• Vital for the success of Commercial Biologics QC, this role provides support for strategic leadership and oversight of daily operations. Responsibilities include managing commercial specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program. The role will contribute to monitoring QC test method execution and leading the analytical lifecycle management of commercial biologics drug substances and drug products.

Requirements:

You have:

• Experience with Biologics Quality Control sub-functions and extensive knowledge of industry best practices and trends.

• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. 

• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. 

• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness. 

• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. 

• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.

• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision. 

• Demonstrated the ability to influence process and outcomes across functions.

Qualifications:

• 10+ Years’ experiences with BS, OR 8 + Years with MS OR 2+ years of experience and PhD in Chemistry, Biochemistry or related field. 

• Deep knowledge and experience in Biologics 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.