Gilead Sciences, Inc.
Scientist — Quality Control Biologics- Reference Standard Lead
Gilead Sciences, Inc., Foster City, California, United States, 94420
**Key Responsibilities:** The Scientist, Analytical Lifecycle Management is vital for the success of Commercial Biologics QC, providing support for strategic leadership and oversight of daily operations. Responsibilities include supporting Commercial reference standard, raw materials, and critical reagents programs, and specification strategies.role will contribute to monitoring QC test method execution and**Job Responsibilities** Experienceoverabroad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends. Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions. Demonstrated the ability to motivate and engage individuals. Demonstrated the ability to influence process and outcomes across functions. **Basic Qualifications:**
Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience ORBachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience ORAssociate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience ORHigh School Degree and 10+ years of relevant experience
Experience developing and/or leading reference standard and critical reagent programs for commercial or late-stage biologics drug substances and drug products. Experience authoring reference standard and critical reagent qualification and stability protocols. 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. Stays ahead of shifting trends in industry. Strong organizational and planning skills. Shows excellent verbal and written communication skills and collaborative interpersonal skills. #J-18808-Ljbffr
Master's Degree in Chemistry, Biochemistry or related field and 4+ years of relevant experience ORBachelor's Degree in Chemistry, Biochemistry or related field and 6+ years of relevant experience ORAssociate’s Degree in Chemistry, Biochemistry or related field and 8+ years of relevant experience ORHigh School Degree and 10+ years of relevant experience
Experience developing and/or leading reference standard and critical reagent programs for commercial or late-stage biologics drug substances and drug products. Experience authoring reference standard and critical reagent qualification and stability protocols. 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. Stays ahead of shifting trends in industry. Strong organizational and planning skills. Shows excellent verbal and written communication skills and collaborative interpersonal skills. #J-18808-Ljbffr