Scientist I, MSAT (Upstream)Location 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.
The Manufacturing Sciences and Technology (MSAT) department at BioMarin is the technical partner for clinical and commercial operations and actively supports manufacturing processes throughout the product lifecycle. We are an inclusive, high-performing, highly motivated, and collaborative group looking for an innovative and passionate individual with strong cell culture skills and an engineering background to become an integral part of our upstream team. You will join a team of scientists and research associates working to resolve manufacturing challenges, evaluating new technologies, and facilitating continuous process improvement to ensure robustness for our biologics and adeno associated virus (AAV) viral vector production process.
Majority of the work will be lab based involving insect and mammalian cell culture, lab-scale bioreactor operations, and analytical methods execution. The selected candidate will lead projects to improve our understanding of large scale fed-batch and perfusion bioreactors, and develop solutions to resolve cell culture issues. This position requires a high level of technical expertise in therapeutic protein expressions systems at commercial scale. Applicants who have hands-on experience with molecular biology and cell culture techniques are desired. Applicants must have strong communication, project management, and leadership skills as they will regularly interface with Analytical Chemistry, Quality, Process Development, and Manufacturing teams.
Projects may include, but are not limited to:
- Investigate the impact of raw materials on biologics and AAV viral vector process performance, and develop strategies to control their effects
- Develop small-scale model systems to investigate process deviations under large scale bioreactor conditions
- Establish high throughput experimental platforms for rapid screening of raw materials and process conditions
- Optimize and troubleshoot cell-based assays
- Identify factors affecting robustness of cell transfection in commercial processes and design strategies to control for these factors
- Knowledge of, and experience with, fed-batch and/or perfusion bioreactor assembly, operation, and theory in a commercial manufacturing and/or laboratory setting
- Experience working in cell and gene therapy and/or biologics in industrial or academic settings
- Possess advanced skills in experimental design (e.g. DOE), data analysis (e.g. PCA, Discriminant Analysis, PLS), and problem solving
- Demonstrated scientific expertise through independent scientific thought, as evidenced by original peer-reviewed publications
- Ability to work on multiple projects and adapt to fast-changing environment
- Excellent oral and written communication skills (e.g. report writing, good documentation practices)
- Demonstrated ability to operate both independently and in team settings
- Knowledge of, and experience with, analytical assays such as HPLC, Octet, ddPCR, RT-PCR, Western Blotting, ELISA
- Experience with, and a passion for, mentoring and teaching colleagues
- Ph.D. in Chemical Engineering, Biochemical Engineering, or related discipline with 0-2+ years experience in process development or manufacturing support; or MS with 5+ years of relevant experience; or BS with 8+ years of relevant experience.
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.