Manager, Reference Standard

4 weeks 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.

Manager, Reference Standard & Critical ReagentsThe Reference Standard & Critical Reagent Manager is a leadership position in the Novato Quality Control team, reporting into the Head of Novato QC, focused on leading a team of QC analysts and associates to support and maintain the global program management of reference standards and critical reagents used in the testing and release of late-stage clinical and commercial products. The Manager works in collaboration with Technical Development counterparts, Product Quality Leads, and other testing sites to ensure continuous supply of qualified Reference Standards and Critical Reagents for the global network.Detailed Responsibilities: Department Leadership and Management

Collaborate with QC Functional Head and People Department to identify needs and participate in recruiting, hiring, and promoting staffLead and develop a cohesive, balanced, and high functioning team focused on producing high quality deliverables and outcomesOptimize the organizational design and allocation of team resources across the team to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiativesMentor, coach and inspire the team on BioMarin skill and career developmentEnsure all individual training and guidelines are kept currentSet short- and long-term Reference Standard & Critical Reagent Management team goals oriented to a high performing function (e.g., Objectives and Key Results (OKRs))Manage annual budget, operational expenditures, and forecasting activitiesDefine team operational priorities to ensure timely completion of reference material and critical reagent testing and results documentationPartner with Technical Development and QC leaders to ensure consistent strategies and supply for laboratory reference standards and critical reagents Reference Standard (Late-stage Clinical and Commercial)Manage the reference standard qualification / requalification lifecycleManage the qualification of alternative / replacement reference standards, as applicableAuthor or oversee authoring of reference standard technical protocols including qualification, requalification and reports including expiry extension and qualified ranges, etc.Oversee monitoring of manufacturing schedule and request materials to be used as reference samples, and coordinate supporting activitiesManage and resolve escalated issues and risks as appropriateLead the development of global business practices, policies, and standards for product reference standards, including qualification, resupply, and inventory management Critical Reagent Management (Late-stage Clinical and Commercial)Develop, manage, and optimize processes and projections for critical reagent supply planning including inventory management, logistics and space planning Oversee Critical Reagent lifecycle management across the portfolio of products (new and existing) including for new methods / method replacement, work instructions for qualification, and qualification of alternative / replacement reagentsOversee monitoring of manufacturing schedule and request materials to be used as critical reagents, and coordinate supporting activitiesOversee or coordinate the generation of critical reagents with other support areas and / or external contractors as neededOversee the qualification and re-qualification processes of critical reagents to meet standardsAuthor or oversee authoring of protocols and reports for critical reagent expiry extensionAct as the main product Point of Contact in QC organization regarding Reference Standards and Critical Reagent Management for commercial programs
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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