Associate Director, Product Team Lead - Technical Development and Services
Location Cork, Ireland Workstyle Hybrid ApplyWho We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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.
Associate Director, Product Team Lead - Technical Development and Services
Shanbally Ringaskiddy, Cork ( Hybrid)
Closing Date Friday 23rd May 2025
SUMMARY DESCRIPTION
Responsible for Drug Substance technical leadership and oversight of all commercial lifecycle management activities.
Responsible for Drug Substance technical leadership and oversight of all commercial lifecycle management activities.
RESPONSIBILITIES
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Drug Substance technical leadership and oversight of the product family to ensure visibility, integration and coordination of all technical lifecycle activities.
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Drug Substance 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 and manufacturing processes
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 Commercial Support 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 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.
SCOPE
Key Performance Metrics:
Lifecycle management activities delivered on time and budget
Key Performance Metrics:
Lifecycle management activities delivered on time and budget
Successful Health Authority Approvals where applicable
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.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.