Scientist - Quality Control Biologics- Analytical Method Validation and Transfer

Gilead Sciences-posted 3 months ago
$136,340 - $176,440/Yr
Foster City, CA
5,001-10,000 employees
Chemical Manufacturing
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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.

  • Support Commercial analytical method validations and transfers.
  • Oversee compendial review program and specification setting strategies.
  • Monitor QC test method execution.
  • Lead the analytical lifecycle management of Commercial biologics drug substances and drug products.
  • Develop and improve complex concepts, techniques, and standards based on quality principles.
  • Develop solutions to complex problems requiring ingenuity and creativity.
  • Work with senior management to implement Company-wide long-term solutions.
  • Motivate and engage individuals.
  • Influence process and outcomes across functions.
  • Support future laboratory work.
  • 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.
  • Experience authoring validation protocols and reports for commercial or late-stage products.
  • Experience developing method transfer plans, including authoring gap assessments, master transfer plans, protocols, and reports.
  • Experience interacting with and providing oversight of QC activities at CDMOs and CTLs.
  • Experience leading or participating in the development of product specification setting for commercial or late-stage products.
  • 1+ year of relevant QC experience in a GMP Lab environment, including knowledge of analytical testing, familiarity with laboratory instrumentation and GMP systems/software (e.g. LIMS, QMS, Empower) for biologics drug substances and drug products.
  • Experience in Biopharmaceutical or Pharmaceutical quality control.
  • Strong organizational and planning skills.
  • Excellent verbal and written communication skills and collaborative interpersonal skills.
  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Discretionary annual bonus.
  • Discretionary stock-based long-term incentives.
  • Paid time off.
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