Sr. Scientist, MSAT Viral Vector
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. SUMMARY BioMarin has built one of the largest gene therapy manufacturing facilities in the world, showing our steadfast commitment to scientific innovation. As part of the Manufacturing Sciences and Technology (MSAT) group, this position will play a key role in defining our viral vector manufacturing technologies. The individual will spearhead process improvement initiatives and process characterization studies, as well as lead manufacturing investigations for BioMarin's GMP AAV production facility. The candidate will also be responsible for technical support of on-going manufacturing activities, including process monitoring and impact assessments. The ideal candidate will have experience working in a commercial scale GMP environment and with viral vector or vaccine production. RESPONSIBILITIES
Provide strategic and technical guidance for the manufacture of viral products.
Design, execute and lead studies in support of process investigations and process improvements.
Exercise technical discretion for quantitative analysis of manufacturing process data and interpretation of results.
Lead investigations to understand and resolve complex manufacturing issues, and assess their potential impact to product quality.
Evaluate new methods and technologies, and implement process improvements.
Contribute to scientific publications and CMC regulatory submissions, as required.
EXPERIENCE Required Skills:
Experience with viral production platforms
Understanding of bioprocess engineering principles (i.e. cell culture and/or purification)
Viral vector production/processing experience
Statistical design of experiments (DoE) experience
Multivariate Data Analysis (MVDA) experience, including familiarity of PCA, Discriminant Analysis and PLS.
Extensive knowledge in GMP manufacturing operations and process transfer.
Demonstrated skill in leading teams tasked with resolving complex manufacturing related issues.
Ability to perform data analysis and interpret and present results in written and oral formats
Must be well organized, with the proven ability to manage complex projects that involve multiple stakeholders.
EDUCATION PhD 3 yrs, M.S. 8 yrs, or B.S. 10 yrs in Chemical/Bioengineering Biochemistry, Biology, or other related scientific discipline SUPERVISOR RESPONSIBILITY Depending on experience 0 - 2 Research Associates or Process Engineers. #LI-SM1 ~BIO