Analytical Science & Technology Lead (ASTL) - Small Molecule

The Manufacturing Science and Technology (MSAT) Analytical Science Function is a global team supporting GSK’s new product introduction into the market and manufacturing sites with projects aligned to technology transfers, second generation processes and critical investigations with supply impact.   Job Purpose: The Analytical Science and Technology Lead (ASTL) is responsible for the leadership and delivery of business-critical projects to support all the analytical aspects related to the late phase of the product lifecycle for key GSK products. The ASTL is accountable for several key GSK products. The role is responsible for managing and defining comparability studies and suitable characterisation strategies to support post-approval changes. The ASTL has end-to-end ownership for the Analytical Product Strategy, taking accountability from the R&D Analytical Leader at first wave approval.   Key Responsibilities (include..,): •            To provide technical analytical leadership for programs, projects and activities related to the specific product/s under the ASTL accountability to ensure business priorities and targets are met e.g. NPI, product transfers, change management, regulatory submissions •            To be accountable for the Analytical Product strategy (APS). Maintenance and update of the APS through the post-approval product lifecycle eg. recommending specification and stability strategies, recommending novel analytical technologies based on product needs. Ensure that analytical methods developed by R&D are robust with respect to product lifecycle, focusing on the highest risk / most complex methods •            To manage and define comparability studies and suitable characterization strategies to support post-approval changes for the accountable product/s. To compile and recommend acceptance criteria for release and stability tests to feed into the comparability strategies around TT process, change scale, material change.  •            To provide analytical input and expertise into comparability protocols and reports, taking into account non-routine physical properties data and recommendations from Materials Science for regulatory changes/documents and ensure Q&A follow-up during submission process •            To partner with teams across the business in a matrix-fashion in order to meet asset needs, and to identify and mitigate risks i.e. with R&D, GSC (site and central), Technical (site and central), and Regulatory  •            To ensure that the method knowledge is embedded in the onward Technical Transfer to other GSK sites and to external sites •            To drive evaluation of new technologies, including PAT, for analytical testing related to the Product control strategy •            To support sites by providing expertise for analytical aspects of root cause analysis investigations (RCA) in the frame of complex investigations related to the accountable product •            To defend APS for the accountable product/s during HA inspections.     Location:   The successful applicant can be based at Ware (UK) manufacturing site or at Upper Merion (USA) site.     About You: This role would suit a highly motivated person with strong leadership and experience working in a cross-functional, global supply organisation with first-class stakeholder management and a track record of delivery.  As a subject-matter expert you will be degree-qualified with excellent scientific knowledge.  The role requires strong relevant knowledge (eg; small molecule) and experience to support new products introduction or complex life cycle investigations.  You must also have demonstrably strong people skills, be resilient and calm under pressure, have a strong continuous improvement mindset, and a proven ability to drive performance. CLOS