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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.
Job Responsibility:
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
Management of staff
Fosters an environment of compliance, strong work ethic and ongoing learning
Ability to take responsibility for complex projects
Effective interaction with peers across manufacturing to create alignment and improvement
Partners with support groups (Facilities, Validation, Quality) to complete scheduled activities
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
Assist with review and approval of documentation including Batch Records and logbooks
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
Initiate and own required Corrective and Preventative actions and lead change control actions
Support the closure of manufacturing discrepancies and change requests
Support trending and communication of defined department metrics
Identify and drive opportunities for process & business optimization
Translates company and department goals into actionable objectives for self and staff
Requirements:
B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience
4+ years of directly related industry experience, including at least 2+ years with proven leadership role
Ability to independently manage work, actions and expectations is essential
Strong knowledge and experience in all aspects of relevant process theory, equipment, and compliance
Proven experience with relevant process, theory and equipment
Experience with process automation and functionality
Complete understanding and adherence to cGMP’s as related to commercial operations
Current understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products
Experience with business systems (Process historian, LIMS, Trackwise, ERP, MES)
What we offer:
company-sponsored medical, dental, vision, and life insurance plans