Scientist — Quality Control Biologics; Clinical Analytical Operations

Scientist — Quality Control Biologics (Clinical Analytical Operations)

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.

• Clinical Analytical Operations:
  This role is vital for the success of Clinical Biologics QC, providing support for strategic leadership and oversight of daily operations.
• Managing the release testing supporting Gilead’s Clinical biologics drug substances and drug products.
• Contributing to refining QC procedures across Gilead’s biologics manufacturing network, ensuring compliance with global cGMP and Gilead’s Quality Management System.

• 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 ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gilead’s GMP policies.
• Demonstrated the ability to influence process and outcomes across functions.
• Willing to support future laboratory work.
• Willing to support Commercial QC team.

• 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

• 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. 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.