About the Role:
I am partnering a patient-centric, global pharmaceutical organisation in their search for a Senior Manager of Device and Product Performance to provide technical leadership to the group. This is a global role in a fast paced environment where no two days will be the same.
If you are someone who is motivated by working with passionate people in a challenging environment want the opportunity to take ownership of the drug/delivery business of a leading pharmaceutical company, this could be a role you will thrive in.
The successful applicant will have worked with Biologics and Injectables, have QARA experience in a GMP environment and an understanding of both Medical Device and Pharmaceutical regulatory requirements.
The role is based in Dublin paying £80k-£90k + competitive package.
- 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, both internally, 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 company's diverse portfolio including Biologics, Biosimilar, injectable and respiratory products
- Collaborates and maintains positive leadership links with the drug product analytical development project teams to ensure overall analytical approach to drug-delivery system development is aligned
- Review and interpretation of 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
- Responsible for compilation 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
- Vendor management. 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
- Well-developed communication skills to lead or facilitate effective discussions. Is able to communicate technical and/or project information to key leaders in the business.
- Qualified, pharmaceutical professional with proven succes in the industry, a positive attitude and who wants to progress in a fast paced environment.
- Degree in Science/Engineering with several years' experience of industry experience
- A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements
- 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 a necessity
- Understanding of Design Control requirements and working within a GMP controlled regulatory environment.
- The candidate will be both highly innovative and well organised, having excellent planning
- Previous experience in compiling analytical sections of NDA, ANDAs, BLAs is desirable
If this an opportunity you would be keen to explore, please contact Lillie Fenlon-Billson at Real Staffing on l.fenlon-billson at [... Click Apply...] or [... Click Apply...]311
Sthree UK is acting as an Employment Agency in relation to this vacancy.