Job 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.

RoleShift Lead, ManufacturingGMP personnel throughout BioMarin are tasked with developing drugs for clinical trials and scaling their production for the commercial market. These individuals are responsible for establishing and maintaining BioMarin’s innovative manufacturing processes and facilities, ensuring quality assurance and quality control to meet regulatory standards, procuring essential goods and services to support manufacturing, and managing the global distribution of our drugs to patients.Key Responsibilities

• Leadership  

• Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversight  

• Accomplishes tasks through direct and effective coordination    

• Provides direction and hands-on training for staff   

• Supports the management of staff  with supervisor    

• Lives department values and sets the standards for others to operate  

• Fosters an environment of compliance, strong work ethic and ongoing learning  

• Contribution  

• Ability to take responsibility for moderate level projects   

• Effective interaction with peer Leads across manufacturing to create alignment and improvement  

• Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities  

• Process Knowledge  

• Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance  

• Ability to troubleshoot, identify issues and support resolutions with technical groups  

• Required to perform ongoing operational tasks in respective work area  

• Uses scientific thinking and decision making in daily work   

• Technical Competency  

• Proven experience with relevant process, theory and equipment   

• Experience with process automation and functionality  

• Assist with review and approval of documentation including Batch Records and logbooks  

• Support the closure of Manufacturing owned Quality Records (deviations, change requests)  

• Other duties as assigned.

Technical Documentation
-Provide feedback and/or suggested changes to operational procedures
-Assist in the incorporation of new technologies, practices and standards into procedures
-Capable of writing and reviewing process documents

Quality and Compliance
-Complete understanding and adherence to cGMP’s as related to commercial operations
-Support the closure of manufacturing discrepancies and change requests
-Experience with business systems (PI ProcessBook, LIMS, Veeva, SAP, MES, etc.)

EXPERIENCE
-2+ years of relevant industry experience
-Demonstrated technical expertise in downstream processing
-Working knowledge of process automation and associated process equipment
-Proven organizational, shift leadership and communication skills
-Identify and drive opportunities for process optimization
-Ability to manage work, actions and expectations is essential

EDUCATION
B.A./B.S. desired but not required

Shift Details: Wed/Thurs-Sat 6AM-7PM. Wednesday is rotating.
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.

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.