Packaging – Launch SpecialistLocation Cork, 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.
The Packaging Launch Specialist reports to the Packaging Project Lead and works in a team environment that will be committed to continuous improvement, process understanding, personal development and demonstration of production techniques that will result in agile and compliant packaging operations.
Main Areas of Responsibility:
- Co-ordinating new product launches for the Shanbally site, for example Voxzogo DCC launch
- Managing multiple market launches for existing products in Shanbally (approx. 50 – 60 per year), including Palynziq, Voxzogo, Vimizim, Naglazyme.
- Shanbally site representative at global launch forums, ensuring adherence to product launch plans and the production schedule.
- Lead and demonstrate strong stakeholder management in terms of interfacing with other BioMarin departments in Shanbally and global teams (Material Operations, Capital Projects, Process Engineering, Quality, Packaging Development, Product Artwork Team, MES, )
- Implement a Shanbally launch management process, utilizing six sigma tools to identify opportunities for improvement
- Support and partner closely with peer groups to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions – ensure Manufacturing systems and practices are consistent throughout the organization
- Partner with subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for Commercial Packaging Operations.
- Operational support potential/ as required – Supporting:
- Continuous Improvement Initiatives & Capital Projects
- Comply with cGMP Documentation & Operations
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Demonstratedexperiencein a cGMP environme
- Past experience and demonstrated ability to deliver projects to tight timelines
- Lean six sigma experience preferred
- Strongdemonstratedabilityin the area of communication and strong ability tointeractacross cross-functional
- Degreein science/engineering, operations management or industrial engineeringrequired
- Othercontinuingeducationinitiativeshighlydesirable (e.g. Six Sigma, LeanManufacturing,industry specific coursework)
- At least 3-5 years’ experience in a regulated manufacturing environment with excellentknowledgeofpackaging operations
- Proven project management experience with track record of delivering projects to tight schedules
- Familiarity with project management systems, e.g., Excel, Microsoft Project, etc.
- Demonstratedabilityto partner with other functional groups to achieve business objectives
- StrongknowledgeofcGMPs (US & EU), ISO, ANSI and other regulatory agencystandardsandrequirementsapplicableto packaging operations
- Experienceofsuccessfully contributing to a start-up operation highly desirable
- Strongcommunication and interpersonal skills – oral,writtenand formalpresentationskills
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.