QC Chemist III

仕事内容

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.

Key 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

Essential Duties and Job Functions:

• 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.
• Support Quality Control functions and lab management
• 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

Knowledge, Experience and Skills:

• 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.

Basic Qualifications:

• 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