Senior Director, Head of External Operations, GEO
Hiring Manager: Robert Newell ([email protected])
Description
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.
Senior Director, Head of External Operations, GEO
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
The role of Snr. Director, Head of External Operations, GEO will provide leadership for all manufacturing and packaging operations which take place in Contract Manufacturing locations globally to support BioMarin’s clinical pipeline and commercial product portfolio. The core focus of the role is to ensure timely delivery of quality commercial and clinical product to support patient supply from our CMO network. Our CMO operations span multiple sites (approx. 20) and multiple technology platforms namely, Biologic Drug Substance, Synthetic Drug Substance, Oral Solid Dose, Sterile Drug Product, Combination Products, and Packaging.
The successful candidate will provide leadership to a global team of Managers with responsibility for operational management and oversight of the CMOs and other key suppliers within the BioMarin network. The position reports directly to the Vice President of Global External Operations.
The successful candidate will be tasked with leading the implementation, standardisation, and enhancement of a number of global Process Teams consisting of cross functional representation with members from QA, Supply Chain, MSAT, Operations, and other key functions. These cross functional teams have accountability to deliver approved commercial product from our global network of Clinical and Commercial CMOs to support over $2bn of revenue across 8 commercial products with significant planned future growth. Additionally, this role will have accountability for the delivery of released product to support our exciting clinical pipeline (e.g., Make-Assess-Release and Ready – Run – Release processes).
The Snr. Director, Head of External Operations will be a member of the GEO Leadership Team (GEO LT) where they will have shared accountability for managing the global external supply business, setting our vision and developing and delivering our strategic roadmap. This role will also be a key member of other governance bodies within TOPS and across BioMarin.
Primary Activities:
- Ensure delivery of quality product on time from our CMO network to support clinical and commercial supply plans, proactively resolving issues that escalate from Process Teams (Make – Assess – Release and Ready – Run – Release processes).
- Partner with MSAT, External Quality, and Partner Management team to oversee & support product launch programs, tech transfers, technical changes, labelling updates, etc.
- Manage the trades offs & risks between longer-term strategic programs & day-to-day supply activities.
- Develop the Operations model supporting the teams as they look to standardise work, eliminate waste and focus on cross functional working relationships to ensure product supply.
- Recruit, onboard, & train operations professionals to ensure the team has the appropriate experience & capabilities to provide oversight across the E2E pharmaceutical value chain.
- Manage career development & succession planning for external operations teams.
- Manage CMO performance and develop the CMO relationship through routine cycle of Business Review Meetings (BRMs), Quality Review Meetings (QRM), and Joint Steering Committee (JSCs) Meetings as well as ad hoc visits as needed.
- Lead our strategic roadmap to deliver against agreed targets (eg. lead time reduction, cost reduction, metrics enhancements).
- Partner with Quality, Site Supply Chain, MSAT, and others to develop cross functional goals to drive continuous improvement (Quality, Cost, Delivery, Customer Service) in CMO Operations.
- Represent CMO Operations in the Sales and Operations Planning process.
- Lead development and management of CMO Operations budget and long-range plan (approx. $200m+ annual spend).
- Support the CMO selection process by evaluating CMO capabilities against applicable manufacturing, quality and compliance requirements and needs of BioMarin – both operational capabilities & strategic objectives.
- Support development of strategic partnerships with CMOs.
- Partner with Compliance, Legal and Procurement teams to negotiate Master Supply Agreements with beneficial terms for BioMarin.
- Proactively manage and communicate operational risks across the CMO network and develop mitigation plans in partnership with other functional leaders.
- Develop risk-based strategies for the CMO operations oversight, considering the product life cycle, complexity and CMO capabilities.
- Develop CMO Operations team to ensure BioMarin continues to attract, retain, and engages key talent.
Qualifications/Experience:
- Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering or Pharmaceutical Engineering discipline required.
- Minimum of 15 years of relevant biotechnology or pharmaceutical industry experience within operations, quality, or supply chain.
- 10+ years of direct experience in a GMP manufacturing environment and 7+ years of team leadership.
- Direct and broad experience in GMP manufacturing across multiple platforms (biologics; synthetics; oral dose; parenteral manufacturing; packaging).
- Experience overseeing multiple product launch / NPI / Tech Transfer programs.
- Experience with regulatory agency inspections (e.g., FDA, TGA).
- Previous experience leading global teams in multiple locations.
- Strong leadership track record and experience in operations management with CMOs or internal operations.
- Demonstrated ability to hire, coach and grow leadership talent.
- Experience in developing, implementing and leading a cross functional operations model.
- Strong focus and passion for Operational Excellence and Continuous improvement.
- Track record of delivery on operational improvements across Quality, Cost, Delivery and Customer Service.
- Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing talent.
- Excellent written and verbal communication skills at all levels in the organization.
- Experience managing department budget / spend.
- Ability to travel 25-50%, when required.
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.