Gilead Sciences, Inc.
Quality Control Specialist III - Biologics
Gilead Sciences, Inc., La Verne, California, United States, 91750
Quality Control Specialist III - Biologics
Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
This role is pivotal to the success of the Biologics Potency Testing that will be executed in support of commercial products. Responsibilities include technical leadership of analytical method validations/ transfers for Biologic Products and leading the execution/ troubleshooting of instrumentation and test methods used to demonstrate cell binding and cytotoxicity in mammalian cells.Essential Duties and Job Functions:Proficiently execute Molecular Bioassay techniques such as cell-based assays, ELISA, and receptor binding assays.Work with mammalian cell lines (Jurkat, PC-3, CHO) to determine biological activity of drug product by conducting cell binding assays, reporter assays, competitive binding assays, and cytotoxicity assays. Conduct data analysis and evaluate the quality of data generated.Conduct data review of testing to ensure compliance with appropriate specifications and protocols.Develop subject matter expertise on assigned analytical techniques.Lead deviations, investigations, and CAPAs, particularly in relation to laboratory testing and OOS results.Troubleshoot instrumentation and test methods within QC jurisdiction, as required.Support development, revision, and implementation of procedures to support laboratory testing.Write and execute protocols and reports.Support Quality Control functions and lab management.Coordinate waste management, LEAN, 6S, and continuous improvement efforts as required.Work on more complex, non-routine projects and assignments.Candidate should be self-motivated and organized.Act as Designee for QC Manager.Requirements:6+ years of relevant experience and a BSc, or 4+ years and an MSc in Biology, Biochemistry, or equivalent.Working knowledge of GMPs, GLPs, pharmacopeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.Strong experience and knowledge of molecular biology - based analytical procedures.Experience with analytical techniques such as cell-based assays, ELISA, and receptor binding assays.Strong cell - culture experience and knowledge.Experience in method validation/ method transfers is required.Experience with LIMS, ELN, LES, and Softmax Pro is preferred.Prior industry experience in a Biologics testing laboratory is required.
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Job Description
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
This role is pivotal to the success of the Biologics Potency Testing that will be executed in support of commercial products. Responsibilities include technical leadership of analytical method validations/ transfers for Biologic Products and leading the execution/ troubleshooting of instrumentation and test methods used to demonstrate cell binding and cytotoxicity in mammalian cells.Essential Duties and Job Functions:Proficiently execute Molecular Bioassay techniques such as cell-based assays, ELISA, and receptor binding assays.Work with mammalian cell lines (Jurkat, PC-3, CHO) to determine biological activity of drug product by conducting cell binding assays, reporter assays, competitive binding assays, and cytotoxicity assays. Conduct data analysis and evaluate the quality of data generated.Conduct data review of testing to ensure compliance with appropriate specifications and protocols.Develop subject matter expertise on assigned analytical techniques.Lead deviations, investigations, and CAPAs, particularly in relation to laboratory testing and OOS results.Troubleshoot instrumentation and test methods within QC jurisdiction, as required.Support development, revision, and implementation of procedures to support laboratory testing.Write and execute protocols and reports.Support Quality Control functions and lab management.Coordinate waste management, LEAN, 6S, and continuous improvement efforts as required.Work on more complex, non-routine projects and assignments.Candidate should be self-motivated and organized.Act as Designee for QC Manager.Requirements:6+ years of relevant experience and a BSc, or 4+ years and an MSc in Biology, Biochemistry, or equivalent.Working knowledge of GMPs, GLPs, pharmacopeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.Strong experience and knowledge of molecular biology - based analytical procedures.Experience with analytical techniques such as cell-based assays, ELISA, and receptor binding assays.Strong cell - culture experience and knowledge.Experience in method validation/ method transfers is required.Experience with LIMS, ELN, LES, and Softmax Pro is preferred.Prior industry experience in a Biologics testing laboratory is required.
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