Scientist — Quality Control Biologics (Clinical Analytical Operations)

About the position

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.

Responsibilities

• Provide support for strategic leadership and oversight of daily operations in Clinical Biologics QC.
• Manage the release testing supporting Gilead’s Clinical biologics drug substances and drug products.
• Contribute to refining QC procedures across Gilead’s biologics manufacturing network.
• Ensure compliance with global cGMP and Gilead’s Quality Management System.
• Develop and improve complex concepts, techniques, and standards based on quality principles and theories.
• Develop solutions to complex problems requiring ingenuity, creativity, and innovativeness.
• Work with senior management to develop and ensure support for Company-wide long-term solutions.
• Manage and influence Quality Control testing at contract laboratory facilities.
• Support future laboratory work and the Commercial QC team.

Requirements

• PhD in Chemistry, Biochemistry or related field OR Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience OR Bachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience OR Associate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience OR High School Degree and 10+ years of relevant experience.
• 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.
• Proven ability to work with senior management to develop and ensure support for Company-wide long-term solutions.
• Demonstrated ability to influence process and outcomes across functions.

Nice-to-haves

• 1+ year of relevant experience in a Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation.
• Experience with GMP Systems such as LIMS, QMS, SAP.
• Experience with software such as JMP, Discoverant, Empower.
• Experience in Biopharmaceutical or Pharmaceutical quality control.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills and collaborative interpersonal skills.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.