Description

Who We Are

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 

Global Manufacturing Sciences and Technology (GMSAT) 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 ensure robustness of our late-stage gene therapy adeno associated virus (AAV) viral vector and biologics drug substance programs and to accelerate the commercialization of our gene therapy program by facilitating continuous process improvement, evaluating new technologies, and resolving manufacturing challenges.

RESPONSIBILITIES

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 bioreactors and develop solutions to resolve cell culture issues. This position requires a high level of technical expertise in viral vector production, cell culture processes and bioreactor operations.  Applicants who have hands-on experience with plate-based and ddPCR assays 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: 

• Transfer and qualification of scale down models (SDM) during pivotal and/or process qualification drug substance manufacturing of pipeline gene therapy assets.
• Investigate the impact of raw materials on AAV viral vector and biologics process performance and develop strategies to control their effects.
• Design and execute appropriate small-scale studies to investigate process deviations in large scale gene therapy manufacturing processes.
• Optimize and troubleshoot cell-based assays.
• Evaluate Process Analytical Technology (PAT) solutions for implementation at manufacturing scale.
• Evaluate design space for commercial and clinical gene therapy programs.

We are looking for a self-starter, who focuses on transparent and honest communication, is dependable, cares intensely about helping others, and is comfortable making decisions while dealing with uncertainty. You should be familiar with current literature, keep up with new developments in the field, and be able to identify opportunities for innovation. 

EXPERIENCE

Required:

• Experience with fed-batch bioreactor assembly, operation, and theory in a laboratory setting or at a commercial scale
• 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, evidenced by original peer-reviewed publications
• Ability to work on multiple projects and adapt to a 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

Desired:

• Knowledge of, or experience with perfusion bioreactor operation and theory is desired
• Knowledge of, or experience with viral vector production and/or related analytical assays (ELISA, Octet, qPCR, ddPCR, HPLC) is a plus
• Experience with developing and leading technical strategy and projects to meet stated business needs (cost of good improvements, cycle time improvements, variability reduction, etc.)
• Experience with and a passion for mentoring and teaching colleagues

EDUCATION 

• Scientist 1: Ph.D. in Chemical Engineering, Biochemical Engineering, or related discipline with 0-2+ years experience in process development or manufacturing support
• Scientist 2: PhD or equivalent relevant experience plus 2-5+ years industry experience; MS with 8+ years; BS with 12+ years 

Work is primarily onsite in Novato, CA (2 sites located within Novato).  Flexible work from home days permitted when the business allows for it. 

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.