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Quality Control (QC) Biologics - Senior Research Scientist

United States - California - Foster CityQualityRegular
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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 Research Scientist I, Biologics Quality Control- We are seeking several individuals to join our Analytical Lifecycle Management team and Commercial Analytical Operations 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.

Commercial Analytical Operations:

  • Vital for the success of Commercial Biologics QC, this role provides support for strategic leadership and oversight of daily operations. Responsibilities include managing the release testing supporting Gilead’s commercial biologics drug substances and drug products. The role will contribute to refining QC procedures across Gilead’s biologics manufacturing network, ensuring compliance with global cGMP and Gilead’s Quality Management System.

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.

  • Strong organizational and planning skills.

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

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)