Senior Scientist – Large Molecule Analytical Validation
About Our Client:
Our client is seeking a talented Senior Scientist to join their Large Molecule Analytical Validation (LMAV) team. In this role, you will oversee the validation and transfer of analytical test methods for their biologics and vaccines portfolio. Collaboration with cross-functional groups is key to ensure methods meet current regulatory standards and are implemented effectively to support the commercialization of large molecule products. Additionally, you will contribute to the authoring of relevant sections for global regulatory filings.
What You’ll Be Doing:
- Develop method validation protocols and reports, as well as method transfer protocols and reports.
- Utilize project management tools to support validation and transfer activities for pipeline commercialization and inline supply projects.
- Serve as the primary point of contact for internal and external labs during analytical method validation and transfer activities.
- Maintain timelines, oversee the review and approval of validation and transfer protocols and reports, and assist labs with sample and consumable logistics.
- Foster effective communication across functions and departments, aiding management and governance teams in risk escalation, issue management, and mitigation plan development.
- Provide support to subject matter experts and regulatory colleagues in authoring relevant regulatory submission analytical sections.
What You’ll Need:
To excel in this role, you will likely have:
- A Bachelor’s degree in a chemistry or biology related field with a minimum of 5 years of relevant experience, or a Master’s degree with a minimum of 3 years of relevant experience in analytical development or quality control.
- Knowledge of technical aspects and prior hands-on experience with analytical methods used for release, stability, process monitoring, and characterization of protein and conjugate vaccines, adjuvants, monoclonal antibodies, and process residuals.
- Project management experience in tracking, supporting, and communicating timely delivery of milestones.
- The ability to work independently and within cross-functional teams, both in-person and remotely.
- Strong knowledge and experience in applying current Good Manufacturing Practices to analytical activities within a quality management system.
- Familiarity with current major market regulatory frameworks and prior experience in preparing regulatory submissions in a common technical document format.
About Us:
IMC Recruitment is a leading talent solutions provider in the life sciences industry. We are dedicated to connecting exceptional talent with outstanding opportunities, driving innovation in healthcare.
Equal Opportunity Employer:
IMC Recruitment is an Equal Opportunity Employer, committed to embracing diversity and fostering an inclusive workplace.
If you’re ready to contribute your expertise to meet challenging healthcare needs, please apply today.
You can contact me directly at:
Email: ryan.murphy@imc-group.co.uk
Phone: 07483953612
