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 vaccine discovery in Cambridge, we are building new laboratories that will be focused on the development of state-of-the-art methods that will be supporting deep product understanding, process and product development, as well as testing of pre-clinical and clinical samples for new mRNA-based vaccines.
As a Principal Scientist, you will be expected to lead, design and execute scientific studies in support of technical programs as they progress from development into early clinical Phases. You will also ensure implementation of innovative and cutting-edge analytical methods and technologies for mRNA and macromolecule (proteins) characterization and testing in line with Quality by Design (QbD) principles in the area of Phys-Chem and Separation technologies (including and not limited to MS, Chromatography, Electrophoresis, Spectroscopy analyses and techniques used to characterize macromolecules, (e.g. mRNA and proteins, at molecular level)). As a Principal Scientist, you will participate in experimental activities according to defined priorities and will be responsible for the quality of data and presentation of results to internal and external audiences.
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:
- Is independently responsible for the conception, design, implementation of analytical methods and interpretation of scientific and technical data to support projects.
- Design and lead specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework.
- Function effectively as a core team member on multiple concurrent project workstreams and established work processes.
- Solve complex problems through collaborations with others (inside ARD, within Technical RD, with Preclinical and outside GSK), taking a new perspective on existing solutions.
- Generate strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally (inside ARD, within Technical RD, with Preclinical and outside GSK), to strengthen development/ implementation of new methods/technologies, with a specific focus in the preclinical interface.
- Participate and lead the transfer of developed analytical methods within ARD groups (different sites) or other external partners. Analyse, interpret and communicate scientific data effectively within Technical R&D including Technical Development Team and be able to defend scientific and technical decisions at the appropriate technical board.
- Utilize technical process knowledge to meet regulatory requirements appropriate for stage of development.
- Author and review technical documents in support of various project development stages.
- Make sound scientific/technical and business decisions based on a balance of data, analysis and experience.
- Benchmark specific technologies in own functional area to bring innovation and technology to state of the art. Identify opportunities to apply new techniques to address project challenges.
- Contribute and drive strategy and technical development planning and accountability in the execution thereof.
- Collaborate with scientific staff, provide guidance to new team members and act as a resource for colleagues with less experience.
- Lead and implement GxP / EHS / QA rules application.
- Ensure toxicology and development testing and stability are executed with respect to deadlines and in compliance with the expected requirements.
- May represent GSK externally in conferences.
- Act as a voice and ambassador of its department at various internal and external governance bodies and meetings.
Basic Qualifications:
- Degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.
- 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.
Preferred Qualifications:
- Expert knowledge in Mass Spectroscopy, Chromatography, HPLC, Electrophoresis, Spectroscopy analyses and techniques used to characterize macromolecules, e.g. mRNA and proteins, at molecular level.
- Good understanding of QbD principles.
- A good understanding of biopharma / vaccine development process.
- Has worked in a multi-disciplinary team, demonstrates skills in combining different physico-chem and separation analytical technologies in the field.
- Total education and experience in biopharma-related domain of at least 8 years.