Associate Scientist —Quality Control Biologics (Analytical Lifecycle Management)

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.

The Associate Scientist, Analytical Lifecycle Management is vital for the success of Clinical Biologics QC, providing support for strategic leadership and oversight of daily operations. Responsibilities include supporting Clinical specification strategies, reference standards, raw materials, 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 Clinical biologics drug substances and drug products.

Job Responsibilities

• Supports cross-functional teams, embraces continuous improvement, and ensures timely project completion and regulatory compliance.

• 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.

• Willing to support future laboratory work.

• Willing to support commercial QC team.

Basic Qualifications

• Master's Degree in Chemistry, Biochemistry or related field and 2+ years of relevant experience OR

• Bachelor's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience OR

• Associate’s Degree in Chemistry, Biochemistry or related field and 5+ years of relevant experience OR

• High School Degree and 6+ years of relevant experience

Preferred Qualifications

• Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation and GMP systems/software (e.g. LIMS, QMS, Empower).

• 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.