VP, CMC Lead mRNA

VP, CMC Lead mRNA

Position Summary

The VP, CMC Lead mRNA leads a team of CMC leaders and is accountable for the effective leadership of the team and their delivery of process and product development, from commit to candidate to launch, including innovative technology implementation, technology transfer, registration.

Reporting to the Head of Vaccines Technical R&D, this strategic role is accountable for success of GSK's end to end mRNA strategy and is a highly visible position, aligning with the highest level of the organisation to ensure product development and portfolio delivery.

Key Responsibilities

• Effective CMC leadership of all mRNA assets, from commit to candidate to launch. It also includes recruiting, developing and guiding CMC leaders, working with product and process development experts to ensure that the proposed product, innovative technology, manufacturing processes and supply chain logistics are sufficient to support clinical trials, transfer to manufacturing site, registration and launch of the product

• Works with CMOs/internal sites to ensure that manufacturing sites and associated logistics are capable of implementing the manufacturing process and supply chain to produce quality product for clinical studies, registration activities and initial commercial supply;

• Leads the assessment of technical, regulatory, quality, logistical and financial risks associated with the physical product development, manufacture and supply;

• Works with GSK leaders in commercial manufacturing and logistics (GSC), therapeutic areas, franchises and R&D new mRNA platforms to ensure well developed product lifecycle plans with clarity on the activities, technologies and resources/capabilities required;

• Timely governance and investment, aligned with therapeutic area and platform development strategy, for progression of mRNA vaccines assets through major lifecycle programs

• Accountable for effective peer review of mRNA project plans and governance papers

• Responsible for robust CMC plans across mRNA portfolio, including maturity increase, expertise building in R&D and GSC, that inform governance decisions on investment progression.

• Define, develop and implement the GSK processes that guide and govern delivery of GSK's new mRNA technology assets through all stages of development, launch and initial commercial batches production, working directly with the CMC Development Board and relevant peer review bodies to ensure the best project plans are enabled.

• Develop and implement a workforce plan that is aligned to current and future needs of the mRNA portfolio and the business and that reflects a diverse and high performing workforce. Work with internal and external partners to establish and develop a pipeline of future CMC Matrix leaders and career development opportunities for existing CMC Matrix leaders.

• Keep abreast of business, regulatory and technology trends emerging from GSK, academia, external industry and regulators that are relevant to the development and supply of mRNA assets and ensure that GSK and/or CMOs are building appropriate capability for clinical supplies and eventual commercial production.

• Ensure alignment with R&D, commercial manufacturing and external partners to enable effective and efficient delivery of mRNA portfolio. This will include providing an aligned CMC portfolio view to share with CMC partners and ensuring a well-integrated 'one-CMC-matrix-team' and a seamless interface between CMC and the project teams, CMC Matrix Leaders, Vaccines Development Leaders, Commercialization Leaders, project managers, the commercial supply chain and logistics organizations and the manufacturing sites, the therapeutic area and Franchise groups, the Local Operating Companies and external partners.

• Core member of Vx Technical R&D Leadership Team contributing to organizational strategy and goals, the development of leaders of the future and the tactics associated with the CMC aspects of development and supply of mRNA assets.

• Create an environment where teaching and learning, empowerment and tiered accountability are core to the ways of working within the team.

• Resolve cross-project conflicts and risks that impact the delivery of mRNA portfolio; develop and implement effective strategies to ensure cross-portfolio problems are resolved.

• Serve as the portfolio interface to one or more of the following: Viral Scientific Area, Therapeutic SA, bacterial SA, Medicines and/or franchise heads. In this role, provide input to partners regarding to cross-portfolio delivery, strategy, and line specific decision-making forum.

Basic Qualifications

• PhD/Eng with 15+ years CMC experience in the development or manufacture of vaccines or mRNA technology
• Project leadership experience, specifically leadership of multi-disciplinary matrix teams
• CMC and supply chain experience, including late phase CMC/supply chain development and commercialisation
• mRNA CMC product development experience

Preferred Qualifications

• Broad and deep understanding of how medicines are developed and brought to market. Demonstrated delivery of a product through the technology transfer process in some capacity.
• Knowledge of global Vaccine CMC regulatory requirements. Experience working at a very senior level with both internal and external groups.
• An influential and collaborative CMC Leader
• Learning agility and desire to learn new things outside of one's comfort zone; willingness to take on diverse and agnostic assignments in product development.
• A track record of developing others at director level or above

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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