Combination Devices Performance Senior Manager
Our Dublin based client requires a Combination Devices Performance Senior Manager to join their team on a permanent basis. The ideal candidate will have previous experience working in an analytical role in a regulated and GMP environment on Biologic, Biosimilar or Injectable products.
• Responsible for providing technical leadership to the group on engineering verification, design verification, device functional stability, defect management, biological evaluation, extractables/ leachables, management of laboratories at 2 sites, specifications & methods development, transport & shipping studies, development of device control strategy
• Represent the device and product performance group on cross functional project teams, by taking responsibility and executing design control activities to support regulatory submissions and approvals on a range of device programs
• Responsible for compilation of the device analytical content of regulatory submissions and responses to support the organisations portfolio including Biologics, Biosimilar, injectable and respiratory products
• Collaborate with and maintain strong leadership links with the drug product analytical development project teams to ensure overall analytical approach to drug-delivery system development is aligned
• Review and interpret analytical data in line with study and protocol objectives
• Trending and statistical analysis of analytical data and compilation of technical reports to support design and development lifecycle
• Work with the program lead to ensure build and develop robust project plans ensuring that all analytical activities are included and linked to critical project milestones
• Compile and review/approval of device test protocols, reports and specifications in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking
• Identify CROs capable of performing device testing to meet EU, US and ROW regulatory requirements.
• Work with the Quality and legal groups to get CROs approved for testing.
• Establish relationship and manage timelines and contracts to support project requirements
• The ideal candidate will be a qualified, experienced pharmaceutical professional with a proven track record of success, a positive attitude and who wants to progress in a fast paced environment
• Degree in Science/Engineering with several years’ experience of industry experience
• Previous experience of working in an analytical role in a regulated and GMP environment on Biologic, Biosimilar or Injectable products pre and post submission is essential
• Previous experience in compiling analytical sections of NDA, ANDAs, BLAs is desirable
• Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage
• Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
• It is essential that the candidate will be both highly innovative and well organized, having excellent planning and communication skills and able to operate across all site teams. In addition, the candidate must be able to work under pressure and have a proven track record of problem solving and effective time management
• Some travel will be required as part of this role
If you would like further Information you can contact the recruiter directly:
Sinead Cullen | Tel: +353 (0) 1 507 9252