Senior Associate, Quality ControlLocation 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.
A Senior Associate, Quality Control within the Quality Control Analytical Technologies team 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, support 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.
Presentation of laboratory results and conclusions, being a key subject matter expert for regulatory inspections, training and educational development of other staff are also expected.
- Wide-range of analytical testing execution expertise such as: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate based assays including ELISAs and cell-based Bioassays, capillary electrophoresis, qPCR, etc.
- Provide technical expertise for analytical methods in QC, support the maintenance of method and analytical equipment performance
- Prepare protocols, summaries, and reports—often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods for life cycle management of clinical and commercial products
- 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, support and document laboratory investigations and deviation investigations to rapidly identify the root cause and to establish effective corrective action(s) with minimal delay
- 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
- Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives
- Promote the scientific visibility of Biomarin and the QC department through participation in national meetings and publications when appropriate.
- Direct personnel management, as applicable
- Other duties as assigned
Bachelor's Degree in Biology, Biochemistry, Chemistry, Molecular Biology or related field, with at least 5 years relevant experience
Master's Degree Biology, Biochemistry, Chemistry, Molecular Biology or related field, with at least 2 years relevant experience
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.