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Director/Product Technical Owner

Location Novato, California
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

Responsible for end-to-end technical leadership and oversight of all commercial lifecycle management activities.

Responsibilities

  • End to end technical leadership and oversight of the product family to ensure visibility, integration and coordination of all technical lifecycle activities.
  • Provide technical and practical expertise and support across modalities for the involved platform focussed on new product development, manufacturing processes, material aspects & packaging.
  • Drive process and manufacturing technology activities across the platform product family network, working closely with the manufacturing sites (Internal / External) to improve capability and add value.
  • Drive standardisation activities across the platform product network.
  • Support Process Stewards and Frontline by standardising and optimising related technical processes across the network.
  • Supporting submission and implementation strategies with relevant stakeholders (e.g. regulatory approvals, planning).
  • Management and scientific support of product transfers from Process Sciences and manufacturing sites (internal / external).
  • Perform technical feasibility assessments for product transfers in close collaboration with relevant stakeholders. Identify potential risks and creating contingency plans as needed.

Education

Bachelor's degree in Sciences (preferably Biochemical Engineering or Biological Sciences. Master of Science or related PhD. degree preferred.

Experience

  • Experience in Biopharma Sterile Manufacturing strongly preferred.
  • 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology)
  • Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of Biologics.
  • Advanced project management experience/skills required including method transfers, and risk assessment.
  • Knowledge of OPEX principles and tools, and knowledge of R&D processes.
  • Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network.
  • Experience collaborating effectively with other functional groups to achieve business objectives.


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.

About our location

Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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