Senior QC Scientist, Biologics Quality Control (GMP Operations & Logistics)

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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.
 

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.

GMP Operations & Logistics:

• This role is vital for the success of Commercial Biologics QC, providing support for daily QC operations. Responsibilities include managing QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead’s LIMS. The role will contribute to QC procedures across Gilead’s biologics manufacturing network, ensuring global cGMP compliance.

Responsibilities:

The Senior Associate Scientist, Analytical Operations is vital for the success of Commercial Biologics QC, providing support for strategic leadership and oversight of daily operations. The Senior Associate Scientist will collaborate with cross-functional teams, supporting the QC team lead on PDM (Pharmaceutical Development & Manufacturing) commercial project teams.

Focus Areas: 

You Will:

• Contribute to the development and implementation of end-to-end Quality Control strategy for Gilead’s portfolio of biologics products.

• Contribute to staff development, budgeting and cost control, and strategic planning of the Biologics Quality Control department. 

• Demonstrate a clear understanding of biological product testing methods and assays for effective troubleshooting and remediation of atypical results.

Requirements:

You have:

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

• Experience with or demonstrated capacity to learn 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 support for Company-wide long-term solutions.

• Demonstrated an a