Director, Launch Excellence

Location Dublin, Ireland Workstyle Remote Only Apply

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

SUMMARY DESCRIPTION

The Director of Launch Excellence is a new role in the Product Supply Chain Management organization. Director, Launch Excellence will ensure enterprise governance and frameworks for new product launches and artwork and labelling are implemented with quality and timeliness to elevate BioMarin’s launch discipline. Reporting to the Executive Director, Product Supply Chain Management, the Director, Launch Excellence will partner closely with Product Teams and cross-functional launch teams to develop launch disciplines and establish consistent tools, processes, and KPI dashboards, ensuring launch excellence against specific business deliverables.

The ideal candidate will have strong leadership and team development skills, a deep understanding of Product Launch (New Product Introduction), Project Management and Artwork & Labelling with demonstrated ability to drive continuous improvement initiatives.

Note that individual responsibilities may include all or part of responsibilities defined below depending on individual experience and abilities and may change to best support on‑going business needs.

RESPONSIBILITIES

·Mange team to drive launch processes, disciplines, and toolkits including blueprints, frameworks, archetypes, playbooks, governance models that are standardized and utilizes across all products and launch teams.

·Create communities of practice across for upcoming launches to be able to gather, aggregate and share best practices and cross-functional perspectives across teams, ensuring that teams are building on launch and artwork and labelling learnings across the organization

·Manage a consistent and robust product launch process and governance as a ‘control tower’ structure to provide oversight and to ensure consistency of tracking and incorporating disciplines across launches

·Work with internal launch stakeholders to ensure launch process management and successful completion of launch readiness tasks (standardized approach across business units – including Blueprint / Playbook, Governance, and Dashboards /KPIs.

·Work with cross-functional team to understand the impact of changing regulations, product requirements and new market entry regarding artwork and labelling.

·Coordinate Launch Readiness Review Assessments across launch brands to ensure strategic and tactical plans are reviewed and aligned with CtF (commit to file) and CtL (commit to launch) dates with BU and TOPs leadership

·Establish reporting dashboards to manage reporting of key metrics and KPIs including leading and lagging indicators to ensure launch success, providing mechanism for teams to share critical updates.

·Leading overall business planning working with the Product Teams, Commercial / Country leaders, Planning & Logistics as well as cross-functionally to ensure that strategic planning & financial-planning deliverables are created at a high-level and in a timely manner

·Designs and establishes new processes, as required, for new modalities and emerging technologies that warrant deviation / modification of standard processes.

·Create and manage change control packages in product life cycle management system, ensure documentation is accurate and appropriate.

·Team Leadership: Lead, mentor, and develop a matrix team of TOPS professionals, fostering a culture of excellence and continuous improvement.

·Compliance: Ensure compliance with all relevant TOPS and Regulatory policies and processes.

·Stakeholder Collaboration: Collaborate and consistently communicate with key stakeholders, including BU leadership, TOPS product teams and leadership.

·Technology Utilization: Leverage appropriate technology and systems to streamline processes and improve data accuracy to support Product Launch Dashboards.

·Change Leadership:As a member of the Product Supply Chain Team(s) support and drive the change management requirements through communication internally and externally, developing the vision for Launch Excellence and broader PSCM and GSC organization and empowering team members to make effective decisions.

SCOPE

This role is responsible for supporting the on-time Launch and availability of products and artwork and labelling in marketin compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin’s commercial products are delivered to patients in a timely and compliant manner.

The candidate should demonstrate the following attributes:

·A firm commitment to BioMarin’s cultural beliefs and values

·Consistent track record of exceeding objectives within area of influence

·Ability to multitask effectively within a highly dynamic environment

·Ability to achieve results through others without direct reporting lines

·Strong problem-solving skills with a global focus both internally and externally

·Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry

·Flexibility and ability to deal with changing priorities without losing sight of the overall business, product and market needs

·Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change

·Proactive and energetic outlook with an unwillingness to accept the status quo

·Interaction and collaboration with team members, peers and senior management

·Ability to work independently with strong time management skills

·Ability to operate globally, across different time-zones, work with global and regional functions.

EDUCATION

·Bachelor's degree in Life Science, Engineering, Supply Chain Management, Business Administration, or a related field.

·Preferred: MBA in supply chain management, finance or business operations

EXPERIENCE

·Minimum 10 years of experience in Supply Chain Product Launch or related discipline.

·Experience developing and operationalizing processes, systems and plans for New Product Launches inclusive of Artwork and Labelling.

·Strong leadership and management skills, excellent communication and interpersonal skills.

·Lean-DMAIC expertise, preferably Green Belt Certified or higher

·Project management certification, PMP or equivalent (preferred).

·Strong regulatory and GMP acumen

·Detail-oriented, analytical thinker, problem-solver, and able to work in a fast-paced environment.

·Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk

·Ability to effectively work autonomously and independently

·Proficiency in Microsoft applications and understanding of Office Timeline, MS Project / Project Online, MS Teams, MS PowerBI, SAP, or like technologies

CONTACTS

TOPS and PSCT product teams, GSC Planning, Site SC and Operations, Regulatory (CMC, Labeling & International / EU), Commercial Ops., Master Data team, Logistics, Artwork / Packaging Operations, Quality

SUPERVISOR RESPONSIBILITY

Manage a direct team of 3 – 5 professionals responsible for Product Launches and Artwork & Labelling across BioMarin portfolio of products.

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.

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