Associate Director, Medical Device & Combination Products (MSAT), Global External Operations
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.
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.
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.
Technical BS degree or higher (MS or PhD) preferably in Engineering, Pharmaceutical Sciences or similar.
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
WORK ENVIRONMENT / PHYSICAL DEMANDS
Travel: 10% - 20%
This would arise from time spent primarily at European CMO sites, other travel would include the BioMarin facilities in California, US and Shanbally, Co. Cork.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Internally this person will interact with Process Sciences, Manufacturing, Quality Assurance, Quality Control, Validation, Supply Chain, Finance, Compliance, Legal, Clinical Operations and Regulatory. He/she will also be one of the main contacts for all CMO (Contract Manufacturing Organizations) technical work. He/she will be responsible for optimizing the inclusion and contributions from the Contract Manufacturing Staff, Process Development, Quality and GEO staffs.
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.