Sr. Director, CMO OperationsLocation Cork, Ireland Apply
Location Ireland – Dublin/Cork
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 Contract Manufacturing Operations (CMO) 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 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 and Packaging.
The successful candidate will provide leadership to a global team of approx. 20 colleagues consisting mainly of CMO Managers and Associates 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 Contract Manufacturing and can be based in either our city center Dublin office or at our Cork manufacturing site.
The successful candidate will be tasked with leading the implementation of a newly developed Joint CMO Operations (JCMO) model consisting of six cross functional JCMO teams with members from QA, Supply Chain, CMO MSAT and CMO Operations. These JCMO teams have accountability to deliver approved commercial product from our global network of approx. 10 Commercial CMOs to support $2bn of revenue across 7 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.
The Snr. Director CMO Operations will be a member of the CMO Leadership Team (CMO LT) where they will have shared accountability for managing the global CMO 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.
- Ensure delivery of quality product on time from our CMO network to support clinical and commercial supply plans
- Implement the newly formed Joint CMO Operations model supporting the teams as they develop collaborative, cross functional working relationships to ensure product supply
- Manage CMO performance and develop the CMO relationship through routine cycle of Business Review Meetings (BRMs) and Joint Steering Committee (JSCs) Meetings as well as ad hoc visits as needed
- Partner with Quality, Supply Chain and CMO MSAT leadership to develop cross functional goals to drive improvement (Quality, Cost, Customer Service) in CMO Operations
- Represent CMO Operations in the Sales and Operations Planning process
- Partner with Supply Chain to develop and maintain CMO Network Strategies which will ensure capacity is in place for long term product supply
- Lead development and management of CMO Operations budget and long-range plan (approx. $80m annual spend)
- Lead the CMO selection process by evaluating CMO capabilities against applicable manufacturing, quality and compliance requirements
- Partner with Compliance and Legal 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
- Sponsor CMO Operations Leadership team consisting of line managers of JCMO team members
- 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
- Able to travel ~ 30% of the time.
- 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 (operations, quality, supply chain)
- 10+ years of direct experience in a GMP manufacturing environment and 7+ years of team leadership
- Previous experience leading global teams in multiple locations
- Previous experience in operations management and negotiation with CMOs
- Demonstrated ability to hire, coach and grow technical talent
- Experience in developing, implementing and leading a cross functional CMO operations model
- Strong focus and passion for Operational Excellence and Continuous improvement
- Track record of delivery on operational improvements across Quality, Cost 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
- Broad experience in GMP manufacturing across multiple platforms preferred (biologics; synthetics; oral dose; parenteral manufacturing; packaging)
Leadership Behaviors and Personal Competencies:
Builds partnerships and works collaboratively with others to meet shared objectives.
Develops and delivers communications which convey a clear understanding of the unique needs of different audiences;
Skilled influencer; able to distill complex concepts into concise, salient points.
Holds self and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
Develops people to meet both their career goals and the organization’s goals through coaching, feedback, exposure and stretch assignments;
Effectively develop successful leaders and high performing teams.
Drives Vision and Purpose
Paints a compelling picture of the vision and strategy which motivates others to action.
Understands interdependencies, trends, issues and opportunities; able to synthesize complex information and translate into mid to long-range goals and plans.
Credible, trustworthy and empathetic leader; calm under pressure; can do attitude; relates openly and comfortably with diverse groups of people.
Agility and Flexibility
Handles multiple projects and priorities simultaneously; operates effectively, even when things are not certain or the way forward is unclear.
Able to work in a variety of roles and settings, with a diverse group of people and/or functions.
Able to prioritize and focus on the few critical objectives;
Design simple, flexible organizational structures and systems that can align and adapt with evolving strategy.
High Ethical Standards and Integrity
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.