Analytical Strategy and Lifecycle Scientist Opportunity
This 12-month contract position involves leading the planning, preparation, and management of analytical-related regulatory filings across our diverse portfolio.
The successful candidate will collaborate with cross-functional teams, including analytical development, manufacturing, regulatory, and quality, to ensure timely and high-quality delivery of filing-related documentation.
This role offers the opportunity to contribute to key regulatory submissions, support analytical control strategies, and drive continuous improvement initiatives.
* Lead the planning, preparation, and management of analytical-related regulatory filings across the portfolio, including support for BLAs, ROW submissions, and PAS filings.
* Assist in compiling and reviewing analytical documentation required for regulatory filings, ensuring alignment with project timelines and quality standards.
* Work closely with cross-functional teams to ensure seamless delivery of high-quality analytical strategies.
* Maintain clear and accurate tracking of filing-related activities, milestones, and deliverables, providing regular updates to key stakeholders.
* Contribute to the preparation and implementation of analytical control strategies, including specification management and method lifecycle activities.
* Collaborate with QC and other teams to support troubleshooting of analytical methods and address issues impacting regulatory filings or project deliverables.
* Participate in initiatives to improve the efficiency and quality of analytical-related processes and documentation.
* Ensure all filing-related documentation complies with internal standards, regulatory requirements, and best practices.
Key Qualifications and Requirements
* Working knowledge of relevant principles and concepts of Analytical Strategy and Lifecycle (JOS, Analytical Procedures, Method Validation) and associated GMPs.
* Hands-on experience with a broad range of assays for testing and characterising biological products, such as HPLC, iCIEF, gel, and capillary electrophoresis, and various spectrometry techniques (including MS and absorption), along with ELISAs.
* Understanding of method qualification and validation, supported by knowledge of regulatory guidelines and a commitment to cGMP laboratory operations.
* Proven ability to collaborate effectively with remote colleagues and within a matrix organisational structure, with excellent written and verbal communication skills.
* Strong analytical and writing skills, demonstrated by the ability to analyse complex data, draw actionable conclusions, and author formal reports, technical documents, and scientific communications.
* Ability to work independently on most Analytical Strategy and Lifecycle tasks, demonstrating initiative and responsibility in a regulatory-compliant manner.
* A PhD, MSc, or BSc in Biological Sciences, Chemistry, or related disciplines, with relevant experience in Analytical Strategy and Lifecycle or a related field.