Scientist 1Location 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.
This position will utilize scientific and engineering principles to develop, characterize, and transfer upstream bio-manufacturing processes of AAV gene therapy vectors with minimal supervision. The individual will focus on process optimization and scale-up in the laboratory, utilizing bench-top and pilot scale bioreactor process models. The successful candidate may also perform process transfer, monitoring, and support efforts at one or more manufacturing sites. Bioreactor optimization, scale-up, and development experience is required, including understanding of the underlying engineering principles. This individual must be competent with analysis and interpretation of data and will ideally have molecular biology experience along with plate-based and qPCR assays. The ideal candidate will also have familiarity with large-scale AAV vector production.
- Design and execute studies in support of process technology transfer to manufacturing site including improvement of established manufacturing processes, selection of materials and validation of process parameters.
- Design and execute cell culture process development experiments, perform analytical testing, analyze data, interpret and present results.
- Support technology transfer and GMP manufacturing operations through review of batch records and standard operating procedures, cross-training manufacturing staff, on-floor oversight, data analysis, and assessment of process perturbations as appropriate.
- Perform initial recovery & purification of harvest material, including filtration and chromatography.
- Solve complex issues independently.
- Handle multiple tasks with superb organizational skills
- Set-up and maintenance of multiple pieces of process development laboratory equipment: e.g. bioreactors, analyzers, and chromatography control systems
- Generate documentation for experimental reports to support technology transfer and regulatory filings (development and technical report writing).
- Present data and conclusions from experiments at department and inter-department meetings.
- Design, setup, and oversee evaluation/testing of new and modified process equipment.
- Train fellow employees on cell culture techniques.
- Some travel may be required.
- Experience with cell culture processing platforms. Must be expert with shake flasks and stirred-tank bioreactors.
- Bioreactor optimization and scale-up
- Understanding of bioreactor engineering principles
- AAV viral vector production/processing experience
- Statistical design of experiments (DoE) experience
- Ability to perform data analysis and interpret and present results in written and oral formats
- Some molecular biology skills, qPCR and plate-based assay experience
- Must be proactive and able to design, plan, and perform experiments independently
- cGMP experience a plus
- Downstream processing: harvest filtration and chromatography
- E.coli fermentation and large-scale plasmid DNA purification
PhD +0-2 yrs, M.S. +5 yrs, or B.S. +8yrs in Chemical/Bioengineering Biochemistry, Biology, or other related scientific discipline
Initial direct reports-0. May be asked to hire and/or support supervision of one more Research Associates.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.