Scientist 1, MSATLocation 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.
We are looking for a highly motivated team member with protein purification and or AAV vector purification experience to be a key contributor in Manufacturing Science and Technology (MSAT) Purification and Analytical group. Incumbent will be responsible for improving process understanding and supporting manufacturing investigations of AAV-based gene therapy drug products.
- Perform scale-down or at scale downstream process troubleshooting, summarize findings, and author technical reports/memos
- Design and execute experimental plans to support functions associated with process variability reduction, product quality improvement, and process streamlining
- Conduct root cause analysis, FMEA, and develop corrective and preventive actions to reduce likelihood of recurrence
- Assist with evaluation of downstream process changes
- Mentor and provide guidance to Research Associates
- Communicate with other departments and all stakeholders to drive investigation completion
- Participate and present data as a member of MSAT
- Participate in scientific meetings and produces original peer-reviewed publications.
- Keep current with advances in technologies related to bioprocessing
- Extensive knowledge of chromatography and filtration techniques required
- Design and conduct small-scale experiments to support at-scale purification evaluation with AKTA systems
- Hands-on experience on viral vector purification, depth filtration, Tangential Flow Filtration (TFF), membrane chromatography, H/UPLC, and analysis techniques
- Knowledge of commercial biologic manufacturing operations, cGMP’s, validation, and regulatory affairs
- Maintain and organize accurate records
- Excellent verbal and written communication skills
- Basic formulation knowledge a plus
- PhD in chemistry, chemical engineering, biochemistry or biology or equivalent and 0-2+ years experience in biologic downstream process development
- MS in chemistry, chemical engineering, biochemistry or biology or equivalent and 5+ years experience in biologic downstream process development
- BS in chemistry, chemical engineering, biochemistry or biology or equivalent and 8+ years experience in biologic downstream process development
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.