Supervisor, Manufacturing

1 month ago

Novato, California, United States BioMarin Pharmaceutical Inc. Full time

Who We Are

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.

Manufacturing Supervisor - Night Shift (18:00 - 07:00) Thursday - Saturday and every other Wednesday KEY RESPONSIBILITIES· Leadership

Accountable for the daily operations in area, requiring effective communication to make appropriate decisions, trouble shooting, and schedule adherences with minimal oversightAccomplishes tasks through direct and effective coordinationProvides direction and hands-on training for staffSupports the management of staff with supervisorLives department values and sets the standards for others to operateFosters an environment of compliance, strong work ethic and ongoing learning· ContributionAbility to take responsibility for moderate level projectsEffective interaction with peer Leads across manufacturing to create alignment and improvementPartners with support groups (Facilities, Validation, Quality) to complete scheduled activities· Process KnowledgeStrong knowledge and experience in all aspects of relevant process theory, equipment, and complianceAbility to troubleshoot, identify issues and support resolutions with technical groupsRequired to perform ongoing operational tasks in respective work areaUses scientific thinking and decision making in daily work· Technical CompetencyProven experience with relevant process, theory and equipmentExperience with process automation and functionalityAssist with review and approval of documentation including Batch Records and logbooksSupport the closure of Manufacturing owned Quality Records (deviations, change requests)· Quality and ComplianceComplete understanding and adherence to cGMP's as related to commercial operationsInitiate and own required Corrective and Preventative actions and lead change control actionsSupport the closure of manufacturing discrepancies and change requestsCurrent understanding of FDA and EMEA guidelines, cGMP's for Manufactured Drug Products· BusinessExperience business systems (Process historian, LIMS, Trackwise, ERP, MES, etc.)Support trending and communication of defined department metricsIdentify and drive opportunities for process & business optimizationTranslates company and department goals into actionable objectives for self and staff· Other duties as 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.

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