Associate Director, MSAT (Packaging Engineering and Labelling), 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.
Associate Director, MSAT (Packaging Engineering and Labelling), Global External Operations
Reporting to the Senior Director of the MSAT function within Global External Operations, the Associate Director, MSAT Packaging Engineering and Labelling is responsible for the design, development, testing, coordination, implementation, and maintenance of secondary and tertiary global packaging solutions for BioMarin’s clinical and commercial products globally. Along with this, the role is responsible for leading and managing the process for development of packaging component artwork through external suppliers and internal partners to ensure artwork is provided when required for packaging operations at all domestic and international packaging manufacturers of BioMarin products.
The role is responsible for leading a team fulfilling their responsibilities associated with the Packaging Engineering and Artwork processes. S/he is a key member on project teams to deliver high-quality packaging on schedule, which meets customer, business, and regulatory needs. S/he will also be expected to establish and lead a significant process improvement program to ensure both Packaging Engineering and Artwork processes are scalable to support company growth.
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.
Lead a team responsible for the design, testing, and implementation of secondary, and tertiary packaging components. Also provide technical support to Packaging operations at CMO’s.
Act as Packaging team leader for key clinical and/or commercial programs to ensure delivery of successful packaging solutions
Partner with internal and external packaging teams to identify and implement improvement opportunities regarding package design
Work with and travel to contract sites to jointly develop package systems, batch records, distribution and handling methods, and any activities involved in properly transporting the drug throughout the supply chain.
Leverage business process improvement resources to deliver streamlined business processes within Packaging Engineering and Artwork
Solve technical challenges drawing on a combination of experience, sound judgment, problem-solving skills, engineering first principles, and advanced engineering methods.
Collaborate with Packaging Operations, Commercial Marketing, Regulatory, and contract artwork design companies to develop and manage all commercial artwork activities for Global markets.
Apply knowledge of FDA, EU and ISO requirements related to packaging, ensuring robust package verification and approval.
Support the build out of the GEO MSAT function.
Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs. Oversee the implementation of label changes following regulatory guidance and commercial style guides.
Accountable for ensuring all labelling projects/submissions and implementation deadlines are met from project initiation to delivery of ready to print artwork
Contribute to the development of formal systems and procedures for the selection of CMOs
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 and >5 years managing international artwork development and implementation activities in a GMP environment with a strong technical services/MSAT experience.
Demonstrated development, leadership and implementation of process change programs
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.