Senior Research Associate - Downstream

Description

Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

• Accountable for designing and delivering assigned scientific projects & studies in line with overall BCoE business plan and technical agenda, with limited supervision.
• Accountable for the integrity of the data and scientific conclusions from assigned scientific projects.
• Support and lead root cause analysis investigations, troubleshoot processing problems and support more junior scientists with technical challenges and development of technical depth. Accountable for developing and maintaining small scale models and maintaining expertise in protein purification techniques and methodologies.
• Author protocols, work instructions, SOPs, risk assessments and technical reports to a high standard.
• Use scientific integrity and expertise to challenge the status quo and identify opportunities for improvement in lab practices.
• Accountable for developing & maintaining a high standard of Good Laboratory Practices (GLP).
• Responsible for developing cross functional project plans with other BCoE SME’s and stakeholders.
• Responsible for participating in the internal network of SME’s across the scientific and technical functions namely BCoE, Process Sciences and Analytical etc.
• Responsible for the communication and dissemination of scientific output to scientific & technical functions and BCoE stakeholders. (i.e. presentations to internal functions)
• Responsible for designing discrete studies/experiments with appropriate supervision.
• Responsible for maintaining a culture of empowerment, accountability and continuous improvement within BCoE.
• Responsible for contributing to strong cross functional relationships through promotion of science and the work of BCoE across stakeholder groups, specifically Technical Operations functions.
• Responsible for maintaining a culture of Operational Excellence, namely Standard work and 5S.
• Responsible for adhering to BCoE procedures and practices specifically in relation to laboratory operations.
• Accountable for the health and safety of self and colleagues working together

• PhD degree in a relevant scientific discipline (Biochemistry, biotechnology, process engineering etc) with 0-2 years’ experience of laboratory scale upstream/downstream techniques.

• Master's degree in a relevant scientific discipline (Biochemistry, biotechnology, process engineering etc) with 3+ years’ experience of laboratory scale upstream/downstream techniques
• Master's degree in a relevant scientific discipline (Biochemistry, biotechnology, process engineering etc) with 5+ years’ experience of laboratory scale upstream/downstream techniques
• Commercial scale experience will also be considered. Some experience in analytical science will be an advantage.
• Working knowledge of pharmaceutical regulatory requirements appropriate to level and understanding of the cGMP manufacturing process for Biologics.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.