Investigator - Particle Size, XRPD, and Combination Injection Device Analysis

At GSK, we have bold ambitions for patients, aiming to positively   impact   the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with   cutting-edge   technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.   We’re   uniting science, technology, and talent to get ahead of disease together.     Find out more:   Our approach to R&D   @@HD@@   Role Summary   @@/HD@@ As an Investigator – Particle Size, XRPD, and Combination Injection Device Analysis, you will work within matrix teams to design and perform particle and device testing,   applying   and integrating results from a range of analytical methods and advanced mechanical testing equipment. This role focuses on developing and delivering robust testing procedures and data assessments that enable the selection and refinement of the next generation of GSK parenteral medicines and drug-device combination products. You will play a key role in ensuring that   optimal   combination injection device solutions are provided to patients through your   expertise   in injection device analytics, while working in compliance with GSK policies and applicable regulatory and quality standards.

This role will   provide   YOU   the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:   • Building and   maintaining   your   expertise   in particle science and device testing to help drive innovation and efficiency in analytical development activities.   • Performing and guiding cGMP analytical laboratory experiments and technical analyses to support device and formulation selection and development, including analyses to support release and stability of drug substance, drug product, and combination products.   • Executing and/or supervising the execution of method validation experiments for particle characterization and autoinjector analytical methodologies   in accordance with   regulatory standards and Quality by Design ( QbD ) principles.   • Participating in cGMP analytical method transfers from R&D to commercial quality control laboratories.   • Independently writing and editing sections for patents or regulatory   submissions, and   authoring scientific papers and internal reports.   • Documenting laboratory work   in accordance with   cGxP   expectations, GSK company policies, and legal requirements.   • Reviewing experiments, analytical methods, method validation protocols and reports, stability protocols, and other technical documents for scientific quality and compliance.   • Performing data management tasks, including effective recording of results in electronic laboratory notebooks or other approved systems (e.g.,   tabulating   and graphing results).   • Providing input into, and where   appropriate   leading,   troubleshooting   and problem-solving activities as they occur during the development process.   • Proactively learning, building, and applying prudent data solutions and AI tools to drive efficiency and consistency in daily operations, in compliance with GSK’s information protection, data privacy, and acceptable technology use policies.   • Interpreting results, forming conclusions, and presenting findings to project teams and line management as   appropriate .   • Following all safety requirements for the laboratory and working environment and contributing to a culture of safety and compliance.   • Take a leadership role for safety, regulatory and compliance within their department   • Lead small projects/project sub teams to achieve technical or business outcomes   • Initiate new research directions and novel strategies to achieve “project” and department goals