Principal Scientist, Formulations

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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.

As part of the TRD global organizational evolution and the new US footprint, the Drug Product R&D capabilities have been redefined to meet the newly created vision and mission of TRD located in the Greater Boston Area.  Ambition is to create a globally leading capability in viral vaccines & center of excellence in mRNA by developing a fully functional single location. Consolidation and integration of research capabilities will form communities of practice with critical mass, leverage deep expertise, amplify accountability and result in breakthrough innovations.

The Principal Scientist, mRNA Formulation is expected to lead, design and execute scientific studies in support of the mRNA platform and advanced technologies in vaccine drug product formulation and delivery.

In particular, the Principal Scientist will apply deep expertise in drug delivery systems to the discovery and development of mRNA vehicles, encompassing LNPs, non-conventional nanoparticles and other novel delivery modalities, for conventional and/or alternative routes of administration, in a broad spectrum of vaccine and medicine applications.

Key Responsibilities:

• Independently responsible for the conception, design, implementation, and interpretation of scientific and technical data to support projects
• Identify and optimize mRNA formulations to achieve efficient delivery and validate concept in suitable preclinical models
• Conceive and execute studies to maximize understanding of the relationship between the vehicle/formulation physicochemical profile and functional activity to further drive and refine the rational design of mRNA delivery systems
• Identify emerging technologies/platform for mRNA delivery
• Apply material science and molecular modelling expertise to the characterization of the delivery systems, employing existing technologies and exploring novel concepts for further achieving the understanding at molecular level
• Design and execute experiments to develop a phase appropriate production process, exploring different conventional and emerging technologies, scales and payloads
• Collaborate with internal GMP pilot plant and/or with external C(D)MO for the production of material to be used in clinical studies
• Collaborate with and/or leads scientific staff to design, implement, and interpret the data from development workstreams. Provide guidance to new team members and acts as a resource for colleagues with less experience
• Make sound scientific/technical and business decisions based on a balance of data, analysis and experience.
• Solve complex problems through collaborations with others, taking a new perspective on existing solutions.
• Prepares and presents scientific data within Technical R&D including Technical Development Team and may represent GSK externally (conferences, etc)
• Authors and reviews technical protocol, reports and regulatory document sections in support of various project development stages.
• Communicate effectively within TRD and with external stakeholders and is able to defend scientific and technical decisions at the appropriate technical board
• Benchmark specific technologies in own functional area to bring technology to state of the art

Basic Qualifications:

• PhD with 3+ years of post-doc and/or job-related experience, MS with 6+ years of experience OR BS with 9+ years of experience. 
• Three or more years of expertise in range of formulation processes, including but not limited to microfluidic mixing using benchtop equipment, large-scale mixing, TFF, etc.
• Three or more years of experience in developing CoAs (Certificates of Analysis)
• Three or more years of experience in creating novel bio-analytical