Manager / Sr. Manager, Analytical Services GXP Laboratory San Rafael, United States Onsite Only

Job description

San Rafael BioMarin Pharmaceutical Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Technical Operations 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. The Manager / Senior Manager, Analytical Services GxP Laboratory provides scientific, technical, and operational leadership for analytical activities supporting commercial products and late-stage development programs. This role is part of the global Analytical Services and Commercial Product Support organization and is responsible for leading a team of scientists and research associates engaged in analytical method transfers, method validation, method troubleshooting, remediation activities, stability studies, investigations, and regulatory support within a cGMP environment. The Manager / Senior Manager ensures the delivery of high-quality analytical data, regulatory compliance, inspection readiness, and efficient execution of business objectives. This position partners closely with Analytical Product Leads, Quality Control, Manufacturing, Technical Development Services, Quality Assurance, Regulatory Affairs and external laboratories to support product lifecycle management and commercialization activities. The successful candidate will balance people leadership, scientific oversight, operational excellence, and strategic planning to ensure the Analytical Services organization delivers reliable, compliant, and efficient analytical support across the product portfolio. This role reports to the Head of Analytical Services and Commercial Product Support in Analytical Sciences. Key Responsibilities People Leadership and Talent Development Lead, coach, and develop a team of scientists, Senior Research Associates, and Research Associates within the GxP Analytical Services organization and develop a cohesive, balanced, and high functioning team focused on producing high-quality deliverables and outcomes. Optimize the organizational design and allocation of team resources to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives. Establish clear performance expectations, development plans, provide actionable feedback, and chart career growth opportunities. Foster a culture of accountability, agility, collaboration, innovation, compliance, and continuous improvement. Support staffing, recruiting, onboarding, succession planning, and organizational development activities. Build and maintain a highly engaged, technically capable, and inspection-ready team. Ensure all individual training and guidelines are kept current. Set short- and long-term department goals oriented to a high performing function. Contribute to annual budget planning and forecasting activities, ensuring operational expenditures are in-line with budget. Technical and Scientific Leadership Provide technical oversight for analytical method transfers, validation, qualification, verification, troubleshooting, and remediation activities. Serve as a scientific reviewer and approver for complex technical documents, protocols, reports, investigations, and laboratory studies. Guide technical strategy for analytical method lifecycle management across commercial and development programs, supporting key global initiatives for the organization. Support root cause investigations, complex technical problem-solving efforts, and risk assessments. Drive scientific decision-making using data-driven and risk-based approaches. Operational Management Establish priorities, timelines, and resource allocations to support portfolio objectives and business commitments. Own deliverables for the team and drive accountability at all levels to ensure timelines are met. Ensure efficient laboratory operations, including scheduling, equipment utilization, capacity planning, and workload management. Monitor project progress and proactively identify risks, constraints, and mitigation strategies, escalating constraints to management in a timely manner. Manage and perform activities associated with method validation and transferused to support BioMarin’s programs, including, but not limited to, Contract Testing Organizations (CTOs), In-Country test labs, and strategic partners. Develop and track departmental goals, metrics, and key performance indicators. Drive continuous improvement initiatives focused on quality, efficiency, and operational excellence. Provide technical expertise for analytical methods in QC, including training of analysts as required. Quality and Compliance Ensure compliance with all applicable GMP, GDP, EHS, data integrity, and regulatory requirements. Maintain laboratory inspection readiness and support internal audits, regulatory inspections, and client audits. Review and approve deviations, investigations, CAPAs, change controls, and quality records. Ensure all staff maintain training qualifications and adherence to approved procedures. Partner with Quality organizations to strengthen quality systems and compliance practices. Interpret and apply 21CFR, USP, EP, JP and ICH regulatory guidelines and directives. Interact directly with regulatory agency inspectors during audits. Prepare and review documentation to cGMP standards – often for direct submission to pharmaceutical regulatory agencies. Ensure the team is compliant to GxP and safety and environmental standards. Technical Writing and Documentation Oversight Write, review and approve technical documentation, including analytical procedures, validation protocols and reports, transfer protocols and reports, technical assessments, QMS records, and regulatory documentation. Ensure scientific quality, technical accuracy, and regulatory compliance of documents generated by the team. Support regulatory submissions, health authority responses, and inspection preparation activities. Cross-Functional and External Engagement Represent Analytical Services on cross-functional project teams and governance forums. Partner with Manufacturing, Quality Control, Regulatory Affairs, Quality Assurance, and Technical Development organizations to achieve program objectives. Manage technical interactions with contract testing laboratories, contract manufacturing organizations, and external collaborators. Communicate project status, risks, and strategic recommendations to management and key stakeholders, ensuring alignment to the tier process for escalations. Provide technical support to stakehold