The Site Analytical Sciences senior specialist role is responsible for supporting the Analytical Procedure Life Cycle through end-to-end method lifecycle management, including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method and equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilising expertise in the analytical areas of separations, biochemistry and microbiology.
Bring energy, knowledge, innovation to carry out the following
Technical expertise to support:
- New method introduction (Validation/Tech Transfer)
- New technology introduction
- Assessment and implementation of changes for existing methods and equipment:
- Change in technical element of method, e.g. parameter change
- Change in equipment element of method, e.g. column/reagent change
- Method troubleshooting where cross-functional investigation is required
- Technical SME for regulatory questions, audit support, reagent changes/supply issues to provided justification/rationale for analytical methods and equipment
- Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / compendia changes or updates
- Management of PQ aspect of equipment qualification for all Quality Equipment, support IQ and OQ as required as part of capital projects
- Analytical equipment troubleshooting
- Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed
- Investigation lead/support for lab investigations
- Investigation lead for non-execution related investigations
- Authoring technical documentation in support of investigation and regulatory responses
- Analytical impact assessors on all QC Lab OPS change controls
- Technical Impact Assessment of proposed and finalized compendial changes
- Development and ownership of change control for new analytical methods
- Routine Assay Monitoring and lifecycle management of analytical methods
- Supporting digital method development
Continuous Improvements:
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools
Coaching and Training:
- The Analytical Sciences Team Lead will provide support, guidance and expertise to ensure the success of the Analytical Sciences group; will model leadership behaviours to drive a culture of continuous improvement building a high-performance organisation
What skills you will need
In order to excel in this role, you will more than likely have:
- A PhD with 3+ years of relevant experience, or a Master's degree with 6+ years of experience in the biopharmaceutical or pharmaceutical industry.
- Hands-on experience with a range of analytical methods, such as HPLC, electrophoresis, immunoassays, bioassays, PCR, and microbiological or cell-based assays.
- A talent for managing multiple priorities and projects in a flexible, self-directed way.
- Strong communication and project management skills, with the ability to connect with and influence colleagues at all levels.
- A problem-solving mindset and the ability to make sound, risk-based decisions.
- A passion for coaching and developing others.
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Required Skills:
Adaptability, Analytical Method Transfer, Coaching, Collaboration, Communication, Compliance Awareness, Problem Solving, Project Management, Quality Awareness, Writing Technical Documents
