QC Chemist III
About The Position
This role will be a lab-based role in quality control at La Verne, CA responsible for GMP release and stability testing for drug substance and drug product samples in the biologics laboratory. 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.
Requirements
- Knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)
- Work with electronic laboratory systems such as LIMS, ELN, LES, and EMPOWER
- Troubleshoot instrumentation and test methods within QC jurisdiction, as required.
- The applicant should be an effective communicator of ideas, project goals, and results to team members across cross-functional roles/departments
- Candidates should be self-motivated and organized
- Ability to learn and apply knowledge of GMP/GLP practices in a Laboratory
- Experience with High-Performance Liquid Chromatography (HPLC), ProteinSimple Maurice, and/or Beckman PA800 plus CE
- Able to write standard operating procedures (SOPs), test methods, or protocols
- Perform job functions with a quality mindset
- Working knowledge and proficiency with Microsoft Office software
- Work independently and in a team setting
- Demonstrate good verbal communication skills and interpersonal skills
- Be able to work in a fast-paced and highly collaborative working environment.
- BS degree in Microbiology, Chemistry, Biology, or equivalent scientific discipline with at least 4 years of relevant experience. OR MS degree in Microbiology, Chemistry, Biology, or equivalent scientific discipline with at least 2 years of relevant experience.
- Advanced knowledge of current GMP/GLP practices
Responsibilities
- Perform quality control release and stability testing on drug substance and drug product for product quality assays including but not limited to compendial methods, SEC (Size exclusion chromatography), cIEF (capillary isoelectric focusing), CE-SDS (capillary electrophoresis sodium dodecyl sulfate), CEX (cation exchange)
- Contribute to the method validation and/or transfers
- Perform data review and data verification of laboratory data for early-stage, late-stage, and commercial biologic programs
- Support Quality Control functions and lab management
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
