BioProcess Specialist Drug Substance

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.

• Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
• Own, investigate, write and approve associated deviations as well as support & coach Biotechnicians in these functions – ensure adoption of ‘zero late’ mentality in meeting timelines.
• Ensure areas meet compliance standards and audit areas against standards - highlight any issues and work proactively with the area team and others to ensure resolution.
• Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
• Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.
• Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools
• Develop, define scope and support the implementation of technical solutions under the guidance of site change control systems
• Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high performance team behaviours.
• Effectively and consistently prioritize and delegate daily assignments and projects to technicians and associates. Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.
• Supervise, and perform as needed, employee training in Manufacturing Support, Downstream and Cell Culture operations
• Effectively and consistently prioritize and delegate daily assignments and projects to the technicians and associates.Ensure that all staff understand, properly prioritize, and execute their assignments and adhere to production schedule.

• Demonstrated experience working with NPI processes in production.
• Past experience and demonstrated ability to successfully influence team performance in a high performance team is preferred.
• Strong demonstrated ability in the area of communication and strong ability to interact across cross-functional teams.
• Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.
• Experience with regulatory inspections.

Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience.

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.