Technical Development Leader 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. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. The Technical Development Leader is accountable to lead the CMC development of novel vaccine technologies and vaccine candidates. The role holder will have a unique opportunity to shape delivery of the future vaccine candidates to positively impact the health of up to 2.5 billion people by the end 2030. Key Responsibilities Accountable for early-stage CMC development of novel vaccine technologies and vaccine candidates. Establish comprehensive product technical development strategy (incl. the definition of the technical product profile) in alignment with Vaccine Development Team and Technical R&D functions. As leader of the cross-functional Technical Development Team (TDT), develop, coordinate, challenge and adjust technical development strategy&plans on a regular basis with key members of the TDT. Lead the delivery of the manufacturing process, clinical supplies and CMC sections of the regulatory files. Drive key CMC discussions at GSK internal governing bodies and seek endorsement of CMC strategy, plans, resources, budget, risks and timelines. Accountable for the assembly and quality of technical evidence to support advancement of the project across different stage gates. Ensure the principles of quality by design (QbD) and quality risk management are applied in the development of a robust, fit for purpose, process and product. Identify risks on technical feasibility, timing and resource constraints and drive appropriate remediation/mitigation. Be the primary contact in the context of an outsourcing partnership, as appropriate. Provide regular updates to management and escalate any technical/operational issues impacting project delivery. Basic Qualifications: PhD in Chemistry, Biology, Chemical Engineering, Bioengineering, Biotechnology, Pharmacy or relevant discipline 7 years experience in process and analytical development, scale-up and clinical/commercial development, and manufacturing in the biotechnology or pharmaceutical industry 5 years experience in leading and direct management of process development, and/or manufacturing 5 years experience in mRNA technology based CMC development Preferred Qualifications: Experience in vaccine development processes, knowledge of vaccine manufacturing environment and vaccine industry Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas Excellent leadership, managerial and communications skills in a cross-functional environment Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions Learning agility, high level of autonomy and desire to learn new things outside of one's comfort zone Critical mindset, pragmatic approach in problem solving Expertise or experience in Team/People management/Cross-functional leadership is desirable Spoken&written English J-18808-Ljbffr