Director, MSAT (Drug Product), Global External OperationsLocation Dublin, Ireland Apply
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.
Director, MSAT (Drug Product), Global External Operations
Reporting to the Senior Director of the MSAT function within Global External Operations, the Associate Director/Director, MSAT (Drug Product) is responsible for all technical activities related to commercial/clinical aseptic drug product fill finish activities globally. They will manage a team that leads technology transfers into our contract manufacturers as well as our internal manufacturing sites, management of the technical relationship, project management and product lifecycle management.
This position provides strong leadership for all aspects of drug product manufacturing at CMO’s. Key deliverables will drive problem solving, shareholder management, process optimization and improvement.
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.
Department lead for all technical activities (technology transfers between CMOs and to internal drug product sites)
Lead a team responsible for technical support of the Global External Operations teams concerning day to day activities.
Supporting the qualification of the new drug product facility, line technology, filling processes including fluid paths
Technical development studies to support drug product processes (VHP, ETO, E&L, filling studies, etc.)
Technical SME for issues at CMOs and internal sites related to drug product manufacturing.
Proactively monitor process capability for key processes executed at our CMOs and implement relevant process robustness efforts to improve process capability
Support the build out of the GEO MSAT function.
Technical Assessments for BD and site acquisitions
Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
Contribute to the development of formal systems and procedures for the selection of CMOs
Learn and share knowledge with colleagues and by participating in internal and external scientific presentation opportunities.
Other duties as assigned.
Bachelor’s degree or higher in Science or Engineering is a requisite.
A minimum of 10 years’ experience in the pharmaceutical industry with a strong technical services/MSAT experience.
Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process for aseptic/sterile drug product fill operations. Experience in Oral Solid Dosage is an advantage.
Working knowledge of pharmaceutical regulatory requirements appropriate to level and solid cGMP skills required.
Ability to collaborate in a global team environment at all levels of the organisation
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.
Familiarity with an ERP systems and Trackwise documentation systems are desirable
Demonstrated strong leadership and coaching qualities
WORK ENVIRONMENT / PHYSICAL DEMANDS
Travel: 10% - 30%
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.
This role can be based in Dublin, Cork or Novato.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.