Manager / Sr. Manager, Analytical Services GXP Laboratory

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.
• Optimize organizational design and allocation of team resources to meet the needs of a growing pipeline of products.
• 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.

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.
• 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.
• Manage and perform activities associated with method validation and transfer used to support BioMarin’s programs, including 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.
• Provide technical support to stakeholders and partners during investigations and audits.
• Ensure aligned approaches to GXP activities across sites.

Strategic Planning

• Contribute to departmental strategy, budget planning, capacity forecasting, and organizational initiatives.
• Evaluate emerging technologies, analytical approaches, and regulatory expectations to improve laboratory capabilities.
• Drive analytical science and operational strategies that support product lifecycle management and long-term business objectives.

Qualifications

Manager: Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related scientific discipline with typically 8+ years of relevant pharmaceutical or biotechnology industry experience; or Master's degree with typically 6+ years of relevant experience. Prior experience leading projects, technical teams, or laboratory workstreams. Previous experience leading a high-performing team is preferred.

Senior Manager: Bachelor's degree with typically 12+ years of relevant industry experience; or Master's degree with typically 10+ years of relevant experience. Significant experience leading teams within pharmaceutical, biotechnology, quality control, or analytical development organizations. Experience leading a high performing team is preferred. Strong experience managing regulatory inspections, audits, and compliance programs. Proven ability to influence cross-functional strategy and organizational priorities. Experience managing budgets, staffing plans, resource forecasting, and departmental operations. Recognized technical expertise in analytical sciences and GMP laboratory operations.

Knowledge and Skills

• Strong understanding of analytical method validation, transfer, troubleshooting, and lifecycle management.
• Working knowledge of cGMP regulations, data integrity requirements, and quality systems.
• Demonstrated leadership and project management capabilities.
• Strong technical writing and scientific review skills.
• Excellent organizational, communication, and stakeholder management abilities.