Analyst, QCLocation Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The QC Analyst is responsible for carrying out analytical method development, and troubleshooting work, executing validation and transfer protocols, writing and reviewing protocols and reports, supporting training to site QC, Global QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods, supporting the preparation of regulatory submission documents and, where required, supporting the on-time release, stability, and non-routine testing of pharmaceutical drug substances and drug product.
- Analytical testing performed by the laboratory including: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate based assays including ELISAs and cell based Bioassays, capillary electrophoresis, qPCR, etc
- Testing of in-process samples, finished product, non-routine samples, packaging and stability
- Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- Draft and revise QC SOPs
- Act as technical resource (SME) and train other analysts in areas of expertise
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations and deviations to completion
- Support sample and record management for testing within the group and at CRO/CTO’s
- Manage shipment of materials and samples to other BioMarin sites, CRO/CTO’s, or to in-country testing labs
- Maintain the laboratory in an inspection-ready state
- Interact directly with regulatory agency inspectors during audits
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
- General laboratory management, housekeeping and related duties as assigned
- B.S. in a scientific discipline with 0-3 years of experience.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.