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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. 

We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we’ve invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK’s long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life. 

In the plan to create a new hub for mRNA-based vaccines in Cambridge, we are building new laboratories that will be focused on mRNA state-of-the-art platforms that will enable the discovery and early development of new products including deep product understanding, novel delivery systems and advanced characterization at preclinical as well as clinical stages, supporting the introduction of new mRNA-based vaccines. 

Drug Product (DP) R&D is a core function of the GSK Technical R&D team, accountable for vaccine product and process development from early onset of discovery projects and platforms to late-stage development, transfer and launch of new vaccines.  

The position of Director, DP mRNA CoE and Early Development has been created to lead a team of leaders and talented scientists who will enable the discovery and delivery of new vaccine products, in alignment with company priorities. As the team leader, the incumbent will be accountable for building capabilities in the formulation space, introducing novel delivery modalities for mRNA and proteins, and will establish platformizable solutions to deliver on the pipeline of projects in R&D, from the discovery and preclinical stage to the early CMC development phases. 

The Director, DP mRNA CoE and Early Development will report to the VP Global Head of Drug Product R&D in the Vaccine Technical R&D organization, becoming part of the Drug Product global leadership team, and will have an impact on the broader Vaccine portfolio by reviewing and influencing technical approaches and strategies for CMC research and development. 

While aligning within the DP global team, the incumbent will need to create a strong partnership with the mRNA CoE and research Scientific Areas with solid discovery-interfacing teams, to strengthen focus and boost innovation in Drug Product.

As the most senior leader, the incumbent will be accountable to build strong partnerships with leaders of other functions and the site head. 

The successful applicant will spend 3-6 months within the first year in Rockville, MD to support and guarantee a smooth transition of methods and know-how to the new laboratories in Cambridge, MA. 

Key Responsibilities: 

• Build, establish and sustain a team of talented scientists in the field of vaccine formulation and mRNA delivery. Develop, coach and lead associates on site to create high performing teams.  

• Lead and define technical strategies for formulation discovery and early development of mRNA, with conventional and/or novel mRNA delivery systems, ensuring novel approaches are introduced in the stabilization and presentation of mRNA-based vaccines. 

• Build capabilities on vaccine delivery and adjuvants, to apply transversally across multiple vaccine modalities (proteins, glycoconjugates, VLPs). 

• Define internal priorities and ensure that higher priority activities are resourced adequately, including implementing insourcing and outsourcing approaches. 

• Serve as a member of the global Drug Product leadership team, contributing to strategic planning and collaboration across the TRD global network. 

• Act as a key opinion leader, impacting and influencing strategies within Drug Product, across functions and at senior leadership level. 

• Collaborate effectively with development teams, to ensure continuity in research and development of new technological platforms and/or candidate vaccines, to provide proof of principle and formulation information to establish innovative delivery and new process technologies, to transfer knowledge and technologies for successful implementation at GMP manufacturing sites enabling supply of clinical trial materials. 

• Utilize Quality by Design and other advanced methodologies to enable definition of product profile, manufacturing processes and product presentations.  

• Establish and maintain strong collaboration and interaction both locally and globally with internal (within TRD) and external (Discovery, Medicine Development and Supply, Quality, Regulatory, etc.) partners. 

• Contribute to project plans for delivering CMC strategy and project objectives. 

• Act as the site senior leader for ensuring that EHS standards, site financial targets and relevant/specific site KPIs are met. 

Basic Qualifications: 

• Demonstrated ability to design, manage and deliver on complex projects in the field of science and technology  

• Understanding of external key players in the field 

• Experience in leading a team of scientific experts across multiple sites 

• Experience in transversal function or team management  

• Learning agility, high level of autonomy and desire to learn new things outside of one's comfort zone  

• Strong leadership and communication skills 

#Vx-Cam 

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