5685 Gene Therapy Analytical Technologies, QC Analyst

Duties:
Adhere to 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 products, non-routine samples, packaging, stability, etc. in a cGMP environment.
Assist with the preparation of protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies.
Develop, optimize, validate, and troubleshoot analytical test methods.
Act as a 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/CTOs.
Manage shipment of materials and samples to other BioMarin sites, CRO/CTOs, or to in-country testing labs.
Interact directly with regulatory agency inspectors during audits.
Interface with other departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
Other duties as assigned.

Skills:
Works well independently and in a team environment.
Focused and strong attention to detail.
Theoretical familiarity or experience with analytical methods, such as quantitative PCR / droplet digital PCR, ELISAs, SEC-HPLC, etc.
Familiarity or experience working with insect or mammalian cell lines is not required but preferred.
Motivated learner and able to follow and adhere to procedures.

Keywords:
Education: BS in Biology, Molecular Biology, Chemistry, Biochemistry, or similar fields.
0 – 3 years experience.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.