VP, Head of Analytical Science

GSK•Upper Merion Township, PA

About The Position

The VP, Analytical Science & Technology, is accountable for leading the global Analytical Science and Technology organization in MSAT, Global Supply Chain (GSC), to provide enterprise-wide (biopharma, small molecule, vaccine) analytical support and to integrate specialist analytical science capabilities that support quality control (QC), deeper characterization, and comparability. In addition, the role is accountable for driving innovation and modernization of analytical capabilities, industrializing new analytical technologies, implementing platform analyses and automation into modern QC, and establishing an updated regulatory framework for new product introductions (NPIs) and existing commercial projects in GSC. This role manages the integration and translation of analytical and materials science outputs from R&D into GSC. It ensures late‑phase NPI assets have robust analytical and materials strategies that meet product lifecycle needs, and uses these insights to shape the strategic direction of R&D. It is also accountable for setting the strategic direction and developing analytical and materials science capability across the GSC network, and for overseeing the global rollout and implementation of business‑critical standards, including method and specification alignment, comparability protocol best practices, and the material risk assessment process across GSC. Finally, the VP ensures the generation of critical data to support control strategies and to ensure quality, safe medicines reach all our patients, and delivers excellence in quality analytical methods, data, and knowledge to enable key decisions during technology transfer to commercial manufacturing and to ensure supply of all critical products. The global Analytical Science & Technology function comprises a global team of multi-disciplinary Analytical Science & Technology Leads (ASTLs), MSAT characterization hub leads, and scientists at different sites, whose core responsibilities include: • Provide global technical leadership for analytical method transfer, development and optimization, qualification, validation, troubleshooting and investigation, including evaluation of impacts on product stability, control and specification strategy. • Deliver decision-making guidance and direct testing support for biophysical, biochemical, biological, immunochemical and immunological characterizations, reflecting the complexity and intrinsic heterogeneity of monoclonal antibodies and antibody-related products, and provide the technologies and criteria used to characterize them. • Provide strategic decision-making and direct testing for physical properties testing, spectroscopy, imaging, surface analysis and materials science characterization of established and new small-molecule portfolios. • Develop analytical methods for critical quality attributes and product characterization and provide strategic guidance across-product for critical quality attribute assessment, control strategy, specification setting and comparability criteria. • Present strategic recommendations across the analytical network and ensure the team of ASTLs serve as key scientific and technical representatives on cross-functional teams (CMC, Regulatory, Quality, Manufacturing, R&D, etc.). • Develop analytical testing plans for internal laboratories or for contract manufacturing organisations (CMOs) and provide technical oversight for outsourced testing. • Build strong connections to the GSK Global Supply Chain regulatory and technical agenda and business interests by ensuring operational excellence while introducing new ways of working and interactions through the MSAT hubs and all supporting organisations. • Develop comprehensive product characterization packages to support regulatory filings and actively support GSK Global Supply Chain positions with EU, US and other regulatory authorities as technical expert leaders.

Requirements

Master’s degree in a relevant science or engineering discipline, or equivalent industry experience.
Experience leading significantly sized departments or functions, with leading leaders and delivering strategic scientific leadership in a pharma/biotech organization
15+ years’ experience with a PhD, or 18+ years with an MS, or 20+ years with a BS in a scientific discipline (e.g. biochemistry, biology or a related field), including 7-10+ years’ experience in analytical development and/or testing.
Experience with analytical methods, current cGMP and US/EU/ROW regulatory requirements, and statistical data analysis.
Experience in assay development and qualification.
Experience in regulatory document writing, review and audits.
Experience across primary and secondary manufacturing and across small and large molecule domains.
Experience influencing across supply chains and manufacturing sites, procurement, strategy and R&D.
Experience managing global direct and matrix teams.
Experience developing leaders at director level and above.
Experience analysing trend and metrics data (especially related to quality, safety, technical requirements and performance) to drive continuous improvement.
Experience effectively handling and appropriately escalating issues based on risk in a timely manner.

Nice To Haves

PhD in a relevant science or engineering discipline preferred.
Consistently acts and leads with personal accountability for the quality and compliance of the MSAT team and the broader organisation.
Excellent management, communication and interpersonal skills, with the ability to set ambitious goals, drive results, define priorities, and manage and influence individual and team performance; proven ability to organise people and activities to achieve objectives.
Ability to communicate effectively (written and verbal) and influence key stakeholders at all levels of the organisation, both internally and externally.
Expansive, visionary thinker with the ability to drive strategic partnerships and long-term scientific strategy.
Strong technical and business acumen.
Proven relationship builder with negotiation skills.
Thrives in a fast-paced environment with potential for significant change and remains calm and effective under pressure and in conflict.
Deep understanding of the complexity and interdependencies of development activities required to deliver a commercial manufacturing process, including characterization and comparability needs.
Strong appreciation of the key risks and failure modes across development and the commercial supply chain, with the ability to discuss and monitor these risks effectively.

Responsibilities

Lead and deliver complex, business-critical projects across multiple supply chains and sites, requiring the ability to lead in an environment with a high degree of change and uncertainty.
Lead and develop a large, high-performing team of multi-disciplinary Manufacturing Science and Technology (MSAT) team of subject-matter experts to deliver business-critical projects (more than 100 per year) with continuously changing priorities and deadlines, to avoid significant supply and patient risks.
Serve as a core member of the MSAT Leadership team, responsible for setting strategy and directing training the global Analytical Science & Technology organization, and for ensuring capability across sustainable biopharma, small molecule, and vaccine pipelines in the GSC network.
Be accountable for the global rollout and implementation of business-critical standards, including method and specification alignment, comparability protocol best practice, and the material risk assessment process across GSC.
Be accountable for ensuring late-phase NPI assets have an analytical and materials science strategy to underpin their product lifecycle requirements, and for influencing the strategic direction of R&D in these sciences.
Assure the safety of staff and provide risk oversight for the global Analytical Science & Technology team spanning EU, US and East Asia.
Be accountable for the definition and implementation of the analytical strategy in MSAT, including modernization, and for delivering agreed functional performance, efficiency plans, targets and savings to meet GSC priorities.
Provide technical input into governance boards (Specification Board, Tech Council, Comparability SSO) and influence and support other MSAT heads, R&D leads and senior stakeholders on R&D boards such as the CMC Board.
Create an environment that embraces inclusion to deliver a modern, dynamic working environment across the function, with tiered accountabilities between Analytical Science & Technology Leads, characterization hub leads, and scientists to grow an engaged team.
Ensure alignment with R&D, commercial manufacturing and external partners to enable effective and efficient delivery of the small- and large-molecule portfolios. This includes providing an aligned analytical-QC view for CMC partners, ensuring a well-integrated ‘one analytical CMC team’, and maintaining a seamless interface between R&D, analytical MSAT and QC; commercial supply chain, logistics and manufacturing sites; therapeutic area and franchise groups; and local operating companies and external partners.