Sr. Director, CMO Manufacturing Sciences & Technology (MSAT)
Location Ireland – Dublin/Cork, California - Novato
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 newly created role of Snr. Director Contract Manufacturing Sciences and Technology (CMO MSAT) will provide technical leadership for all of the technology platforms which sit within the CMO organization, namely, Synthetic Drug Substance, Oral Solid Dose, Sterile Drug Product and Packaging and Package development and will partner with internal MSAT organizations on Biologic Drug Substance technical support.
The person in this role will provide leadership to a global team of approx. 20 colleagues consisting of scientists, process engineers, packaging development engineers and people managers responsible for technical management and oversight of the Contract Manufacturing Organizations (CMOs) and other key suppliers within the BioMarin Contract Manufacturing network. The position reports directly to the Vice President of Contract Manufacturing and can be based in Ireland (Cork or Dublin) or in the US at our Novato, CA location.
The successful candidate will be tasked with building a newly formed team of existing technical experts across platforms within the CMO organization. This effort will require development of a clear strategic roadmap for the group which outlines short, medium and long term technical objectives which will align with BioMarin’s corporate and Technical Operations strategy. Additionally, this role will have accountability for the delivery of ongoing technical transfers taking place as we focus on rationalizing CMOs and driving cost improvements through consolidation and scale up.
BioMarin runs operations at approximately 20 Contract sites where we oversee the production of synthetic API’s, including small molecules, process intermediates and starting materials, Drug Substance Biologics, including E.coli and gene-therapy based products, solid oral dose and aseptically filled Drug Product and Packaging. Internally, CMO MSAT team members also lead the Packaging Development process for all products as well as providing technical support and oversight for our existing packaging facility at the Shanbally site in Cork. The CMO MSAT group also supports internal Sterile Filling operations which are installed in California and are in the process of being installed at the Cork facility.
The Snr. Director CMO MSAT 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 technical governance bodies within TOPS and across BioMarin.
- Build newly formed CMO MSAT function establishing clear team identity, roles and responsibilities and hand off’s with other functions
- Drive improved technical understanding of our processes at CMOs to inform a technical improvement agenda
- Partner with Process Sciences to support the development of pre-clinical and clinical products which require CMO services to meet development goals
- Ensure routine technical support of the CMOs for deviation management, lot disposition, batch record reviews through Joint CMO Operations teams
- Lead technical transfers between CMO sites and provide technical support for Technical transfers from CMO sites to internal sites
- Collaborate with internal MSAT groups to support key CMO projects and establish global standards and policies where appropriate
- Lead development and management of CMO MSAT budget and long-range plan (approx. $20m annual spend)
- Partner with Contract Manufacturers technical functions to ensure development of a technical improvement agenda for BioMarin’s products
- Support the CMO selection process by evaluating CMO/supplier technical capabilities against applicable manufacturing, quality and compliance requirements.
- Ensure that CMC life cycle strategies for products are implemented at CMOs and support regulatory submissions and approvals
- Develop mitigation plans for significant technical risks at CMOs and key raw material suppliers.
- Develop risk-based strategies for the CMO technical oversight, taking into account the product life cycle, technical complexity and CMO capabilities.
- Develop CMO MSAT 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
- Advanced degree in Science or Engineering preferred
- Minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, process development, MSAT)
- 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 technical oversight of and negotiation with CMOs and suppliers
- Demonstrated ability to hire, coach and grow technical talent
- Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages
- Strong analytical, problem-solving, and critical thinking skills
- Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical 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.