Associate Director, Medical Device & Combination Products (MSAT), Global External Operations

Associate Director, Medical Device & Combination Products (MSAT), Global External Operations

BioMarin

Ireland

SUMMARY DESCRIPTION

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 individuals 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.

Reporting to the Senior Director of the MSAT function within Global External Operations, the Associate Director, Medical Device & Combination Products, is responsible for the technical leadership related to commercial/clinical Medical Device and Combination Product activities globally. They will manage a team that leads development and delivery of devices for relevant BioMarin products, including but not limited to; device development and design history, technology transfers into our contract manufacturers as well as our internal manufacturing sites, management of the technical relationship with key external vendors, device project management, product complaint management and product lifecycle management.

This position provides strong leadership for all aspects of Medical Device & Combination Products manufacturing at CMO’s and internally.

RESPONSIBILITIES

  • Support life cycle activities of commercial products and development and commercialization of new combination products.
  • Lead and consult in the development and execution of related device strategic plans for problem-solving and continuous improvement by working with internal and external partners.
  • Partner with key interfaces which include sites, External Operations, Technical Development, Product Development, Quality, Regulatory Affairs, Procurement, and suppliers to ensure delivery of key milestones for device programs in BioMarin.
  • Coordinate the approach for Design Control documentation across projects, leveraging platform strategy.
  • Provide leadership and support to define standard work, strategy development and execution of Design Controls.
  • Author Design Control documents for new products and leads other individuals on supporting documentation requirements.
  • Support Device Risk Management, Human Factors Engineering, and Biocompatibility assessments.
  • Utilize design control expertise to develop value-add solutions to customer needs in medical devices and combination products.
  • Ensure BioMarin has the relevant internal and external technical support relationships in place to assist with device development and laboratory investigations
  • Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives.
  • Make informed cost/benefit decisions based on analysis of inputs, outcomes, risks, and likely return.
  • Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.
  • Other duties as assigned.

EDUCATION

  • Technical BS degree or higher (MS or PhD) preferably in Engineering, Pharmaceutical Sciences or similar.

EXPERIENCE

  • 8+ years of experience in medical device, pharmaceutical or in biotech organizations
  • Significant experience with medical device or combination product commercialization, operations support, and materials/components.
  • Subject matter expert in design controls, deviation management, change control, risk management and the fundamentals of documentation structure/systems.
  • Proficiency in project management, from conception and initiation, through close-out.
  • The ability to view the end-to-end supply chain to understand upstream/downstream impact of actions taken at any node.
  • Execution of device design verification and validation, authoring documentation associated with Design Controls and Notified Body Opinions requests (GSPR).
  • Experience in parenteral drug delivery devices like pre-filled syringes and autoinjectors.
  • Experience in injection moulding or polymer processing, sterile and non-sterile combination products.
  • Knowledge of regulatory requirements for combination products worldwide, with experience in FDA regulations and EU-MDR and Notified Bodies.
  • Ability to collaborate in a global team environment at all levels of the organization
  • Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
  • Demonstrated ability to project manage technology transfer and/or new product launches.
  • Use of Lean Six Sigma tools in continuous improvement projects.
  • Excellent organizational, written and verbal communication & negotiation skills.
  • Experience with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment is an advantage.
  • Demonstrated strong leadership and coaching qualities

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Ireland     Manager and Executive     Manufacturing and Logistics     Medical Devices     Quality Assurance     BioMarin    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies