Vice President, Global Manufacturing Sciences & Technology (MSAT)

Location:  Novato, California Category: Manufacturing Science and Technology

Description

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.

Summary:

The VP of Global MSAT is tasked with providing strategic and operational leadership to the MSAT organization, optimizing the use of resources and facilities to support the internal and external manufacturing network, using the most stable and repeatable processes possible.  The role is pivotal in interfacing back through the Development organizations and out through to commercial volume producers, while connecting in with the technical and program project leadership as the molecule transitions from gate 2 through to end-of-life cycle.

MSAT is responsible for successfully transitioning the process from Process Sciences to Commercial, continuously improving process robustness through to end of lifecycle ensuring best possible patient outcomes while creating value for the enterprise. As part of the Technical Operations Group, MSAT leads the technical and process support of commercial Manufacturing utilizing multiple production platforms across an array of Biologic, Small Molecule, and Gene Therapy products, and across Drug Substance, Drug Product, Packaging and Device operations involving both internal and external supply nodes. The range of activities include technology transfer support, process improvement, process characterization experiments in support of validation, investigation of process related manufacturing issues, material science, and analytical laboratory support as required.

Reporting into the Senior Vice President of Global Manufacturing, the VP Global MSAT will be responsible for providing leadership to all MSAT functions across the network. The VP MSAT will be a key member of the Global Manufacturing Leadership team where they will have shared accountability for managing the business, setting the vision, and delivering its strategic roadmap.

Primary Job Responsibilities:

Specific responsibilities include (but are not limited to):
  • Build a strong and scalable MSAT organization that spans across our global network. Optimize the use of resources (human, and laboratory equipment) across the organization in support of improving process robustness and forward-looking capabilities
  • Responsible for improving process robustness through the product lifecycle for all product families within the commercial portfolio. The leader will also be responsible for developing and managing a network-level technical agenda in support of each product’s life-cycle plan.
  • Manage the technical interface to Technical Development, providing technical representation into the stage gate process from stage gate 2/3 to end of life/product retirement and defining/developing the next generation of production technologies.
  • Ensure stewardship for key modalities (Drug Substance, Drug product, Packaging development and Devices), with sufficient process oversight and expertise for each process step.
  • Ensure robust processes exist to support technical transfers and integration of new technologies.
  • Establish and maintains technical services in support of our internal and external manufacturing network, including materials management and data analytics.
  • Provide leadership for the execution of process validation and process comparability activities. Engaged in technical reviews of regulatory filings and responding to questions received from health authorities.
  • Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing)
  • Collaborate with and influence other TOPS Leaders in establishing 5-year strategy and defining enabling objectives. Serve as a thought partner with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering colleagues.
  • Contribute as a key member of the Leadership team for Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.
 Education
  • Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering or Biochemical Engineering discipline required. PhD in relevant life science, chemistry, or engineering discipline highly desired. Experience in gene/cell therapy manufacturing preferred.

 Experience

  • Minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, quality, supply chain)
  • 10+ years of leadership experience in MSAT or other Process Development function
Supervisory Responsibility
  • Circa 100 staff

Key Competencies

Strategy Development:
  • The ability to create and articulate an inspiring vision for the organization, not only for the areas s/he is directly responsible for, but the enterprise.
  • The inclination to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
  • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.
  • The ability to effectively balance the desire/need for broad change with an understanding of how much change the organization is capable of handling, to create realistic goals and implementation plans that are achievable and successful.

 Executing for Results:

  • The ability to set clear and challenging goals while committing the organization to improved performance, tenacious and accountable in driving results.
  • Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
  • A leader who will be able to take calculated risks founded on data and input from others to foresee possible threats or unintended circumstances from decisions.
  • A leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.

 Leading Teams:

  • The ability to attract and recruit top talent, motivate the team, delegate effectively, celebrate diversity within the team, and manage performance; widely viewed as a strong developer of others.
  • The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from followers
  • A leader who is self-reflective and aware of his/her own limitations; leads by example and drives the organization's performance with an attitude of continuous improvement by being open to feedback and self-improvement.
Relationships and Influence:
  • Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
  • An ability to inspire trust and followership in others through compelling influence, powerful charisma, passion in his/her beliefs, and active drive
  • Encourages others to share the spotlight and visibly celebrates and supports the success of the team.
  • Creates a sense of purpose/meaning for the team that generates followership beyond his/her own personality and engages others to the greater purpose for the organization.
  • Able to skillfully leverage deep technical knowledge in a collaborative manner to achieve collective goals.

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.