Lead, Manufacturing (Front End Nights)

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 coordinate the worldwide movement of our drugs to patients. Role Shift Lead, Manufacturing GMP 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, troubleshoot, and schedule adherence 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 Sun/Tues-Sat 6PM-7AM. Saturday is rotating. 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. #J-18808-Ljbffr BioSpace