Sr. Scientist, MSAT Cell CultureLocation 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.
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 continues 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 the coordination of the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The selected candidate will be responsible for spearheading process improvement initiatives, process characterization studies, and lead manufacturing investigations for BioMarin commercial manufacturing cell culture processes. BioMarin’s portfolio of commercial products provides a unique opportunity to work on numerous commercial scale platforms, including mammalian fed batch and perfusion cultures, bacterial fermentation and AAV (viral vector) production. Success in this position requires a highly motivated individual who can provide leadership through previous experiences in the lab and in commercial manufacturing operations.
- Identify opportunities for innovation and capable of generating quality scientific publications with limited assistance from coworkers. Takes primary responsibility for a wide variety of development projects, including shared responsibility for complex projects; carries out experimental work to meet project goals and timelines.
- Provide strategic and technical guidance for the manufacture of biologics and 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 with large scale cell culture platforms, including fed-batch, perfusion, bacterial fermentation and/or viral vector production
- Possess advanced skills in experimental design (e.g. DOE), data analysis (e.g. MVDA), and data presentation. The candidate should be able to integrate experimental design expertise with technical knowledge.
- Extensive knowledge of CMC activities, GMP manufacturing operations and process transfer.
- Demonstrated skill in leading teams tasked with resolving complex manufacturing related issues.
- Well organized, with the proven ability to manage complex projects that involve multiple stakeholders.
- Demonstrated experience of leading a development group of 1 or more research associates, and balancing scientific and the supervisory responsibilities is a plus.
PhD 5+ yrs, M.S. 8+ yrs, or B.S. 12 +yrs in a Chemical/Bioengineering Biochemistry, Biology, or other related scientific disciplines
Depending on experience 0 - 2 Research Associates or Process Engineers.
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.