Analyst, QC Gene Therapy Analytical Technologies
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 providing support to activities related to sample and/or lab equipment management. The QC Analyst is responsible for supporting analytical method development, assisting with troubleshooting work and executing validation and transfer protocols, supporting the writing and reviewing of protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods and when necessary providing support in the preparation of regulatory submission documents. The QC Analyst is responsible to support on-time release, stability and non-routine testing of the pharmaceutical drug substances and drug product in a cGMP environment. This role may include overtime and shift work.
- Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
- Monitor lab equipment for calibration needs, monitoring and tracking of issues related to instrumentation.
- Support the scheduled testing by ensuring the required reagents and glassware are stocked appropriately.
- Maintain the laboratory in an inspection-ready state
- Perform Analytical testing incl: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.
- Testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. in a cGMP environment.
- Assist with preparation of protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- 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
- Interact directly with regulatory agency inspectors during audits
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
- Other duties as assigned
RequirementsBS or BA in Molecular Biology, Biology, Analytical Chemistry, or similar scientific background. Experience working with adherent cell culture, qPCR, ddPCR or similar technologies is highly preferred but not required.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.