Director, Head of Analytical Product Leads

Job description

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 Director, Head of Commercial Analytical Product Leads Shanbally, Cork Hybrid (3-4 days onsite) Closing Date: 21st August 2026 The Director and Head of Commercial Analytical Product Leads (APLs) is a leadership position in the Analytical Services and Commercial Product Support team, focused on leading a team of scientists and research associates in the management of the method lifecycles for new and existing products at BioMarin and third-party CMO/CROs. The Head of APLs will ensure on-time authoring of key CMC / regulatory documentation throughout the method / product lifecycle. Additionally, the Director serves as the Senior leader in the Shanbally site for Analytical Sciences and ensures robust stakeholder management, building strong relationships and representing Analytical Sciences and Analytical Services and Commercial Product Support teams at the site, serving as an empowered decision maker and aligning the team at the Shanbally site to the global team’s initiatives. Key Responsibilities: Department Leadership and Management Exhibits authority and leadership aligned with the goals and initiatives of the Analytical Services and Commercial Product Support, representing Analytical Sciences as the senior leader of the department at the Shanbally site. Meets regularly with Analytical Sciences team members at the site to aid in removing barriers and to ensure directional alignment and timely escalations the Heads of Analytical Sciences and Analytical Services and Commercial Product Support. Ensures Analytical Sciences tier systems are in place at the site, instilling empowered decision-making, triaging and communicating issues to AS leadership, and ensuring escalations are properly documented and resolved. Collaborates with Analytical Services and Commercial Product Support Functional Head and People Department to drive team prioritization and participates in recruiting, hiring, and promoting staff Fosters a cohesive, balanced, and high functioning team focused on producing high quality deliverables and outcomes, driving for continuous improvement and accountability within the team Optimizes the organizational design and allocation of APL team resources to meet the needs of a growing pipeline of products as well as critical non-program strategies and initiatives Actively coaches and inspires the team on BioMarin skills and career development, offering opportunities for increased accountability and stretch assignments Ensures all individual training and guidelines are kept current Sets short- and long-term team goals oriented to a high performing function (e.g., Objectives and Key Results (OKRs) Manages annual budget, operational expenditures, and forecasting activities May support and guide global Analytical Sciences and TDS initiatives at the Shanbally site, including lab expansion activities and is empowered to triage issues and ensure decisions a re made in a timely manner for the Analytical Services and Commercial Product Support team. Aligns technical capabilities and team infrastructure with business and portfolio priorities. CMC Method Lifecycle Oversight Oversees the development of phase appropriate methods and specifications for all products under purview Partners closely with key stakeholders, including Product Quality Leads, and may participate in Quality Partner Teams and CMC teams as required Oversees the development of control system strategies across the portfolio to ensure the implementation of market-appropriate methods and specifications/controls Responsible for ensuring active Method Health Monitoring across the portfolio and prioritization of cross-program activities to address method issues Oversees the development and transfer of methods to all QC testing labs Drives for process improvement initiatives and works closely with partners to ensure feedback loop drive continuous improvement Oversee Method Lifecyle management across the portfolio of products (new and existing) ensuring that the team provides appropriate leadership and accountability, technical support, troubleshooting support and method optimization support to the QC organizations. Aligns analytical strategies across commercial programs and works closely with Clinical Analytical Partner Team Leads to ensure alignment with commercial requirements as programs enter late-stage development. Influences stakeholders to address program gaps and ensures appropriate resourcing to ensure timelines are met Manages and resolves escalated issues and risks as appropriate, communicating issues early and ensuring mitigations are in place as required. CMC and Regulatory Support Establishes an effective partnership with Regulatory Affairs to understand the regulatory requirements for submission and lead time for approvals in the various countries Partners with and influences stakeholders, within TDS and external partners, including External Quality, Novato and Shanbally Quality, TOPS Partner Teams and Value Stream Teams, to ensure analytical strategies are aligned with changing regulatory requirements and are fit-for-future. Drives for holistic improvements to the analytical strategy, ensuring benchmarking with industry partners and to influence late-stage clinical development programs to align with current commercial requirements. C ollaborates with Regulatory Affairs to support CMC deliverables, including content authoring and review of Control of drug substance (DS) and drug product (DP) sections from INDs/IMPDs, BLAs/MAAs and health agency information requests Oversees and approves all aspects of regulatory document authoring, specifically for CTD Module 3 Drug Substance and Drug Product sections, as well as Response to Questions (RTQs) for methods and specifications and any other relevant sections Other duties as assigned. Required Experience Degree in Analytical Chemistry, Genetics, Biochemistry, or similar discipline. BS with 10+ years’ experience. MS with 7+ years’ experience or PhD with 5+ years’ experience. Previous leadership experience (5+ years), managing technical and senior staff, with evidence of building high performing teams. Capable of leading a team while supporting and aligning to broader TDS initiatives and organizational priorities. Exhibits Advanced levels of project leadership, ensuring timelines are met or exceeded by appropriately prioritizing work and building team capabilities. Exhibits strong decision-making skills and is comfortable making decisions with ambiguity. Highly influential and collaborative with demonstrated clear communication, agility, and adaptability to changing environments. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or 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. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.