Who 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.
Principal Engineer - Drug Product Technology Transfer - Cork/Dublin/Hybrid/
Technical Development Services (TDS)are hiring fora Principal Engineer Drug Product Technology Transfer (Sterile)with the following remit.
§Provide technical and scientific leadership to theDrug Product Internal and External manufacturing networkthrough partnerships with global functions and third-party Commercial Manufacturing Organisation’s (CMOs) to introduce new products and technologies.
§Lead Complex Drug Product Tech Transfer programs internally and externally.
§Accountable for delivery of successful process characterisation, engineering, process performance and support to regulatory filingfor drug product.
§Driving excellence in Tech Transfer execution for Sterile Drug Product.
§Serve as the Drug Product representative on Global Drug Product Partner Teams for selected products.
§Development and implementation of Tech Transfer best practices and standardisation across theInternal andexternal manufacturing network.
§Successful delivery of the product development pipeline and commercialisation strategy.
The role will combine scientific, engineering, and operational leadership. This position requires a high degree of familiarity with cGMP and Quality Systems involved with commercial manufacturing processes.
Duties:
Leadership:
§Manage and communicate the key project portfolio milestones to key stakeholders.
§Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions.
§Ability to lead, collaborate and motivate cross functional and matrix teams.
§Serve as a key member of the Global Drug Product Technology Transfer team providing expertise and guidance across internal and external network.
§Partner withDrug Product and Packaging Developmentleadership to provide technical expertise and discussion during GMP audits from regulatory authorities.
§Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools.
§Participate in Global Partner Teams and CMC team as required.
Skills:
§Experience in the Biopharma, experience in Process Development and MSAT/ Technical Developmentorganizations is desirable.
§10+ years of professional experience in the pharmaceutical industry, including managerial experience.
§A broad understanding of Drug Productand a keen sense of business acumen.
§Experience collaborating effectively with other functional groups to achieve business objectives.
§Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
§Demonstrated initiative; results oriented, initiative to institute change.
§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 with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment.
Education:
§Degree in Engineering, Science or Business Discipline
§PhD / master’s in science or engineering Discipline is preferable.
Location
§Ireland - Cork/Dublin/East Coast US
§Travel:15-25%
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.
Equal Opportunity Employer/Veterans/Disabled
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.
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