Principal Scientist, Material Characterization Full-time

Pharmaceutical Science

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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

As a member of Pharmaceutical Science, you will apply your materials characterization expertise to develop a holistic understanding of the relationship between crystal structure, powder properties, drug product manufacture and stability. You will contribute to the development and deployment of state-of-the-art methodologies and technologies to improve understanding of our material and systems to enable the delivery of our medicines. This is highly technical and dynamic environment, requiring close collaboration across multi-disciplinary project teams. You will thrive in this environment if you are able to effectively prioritize and manage multiple tasks, communicate your recommendations clearly, seek input from SMEs and wider team members, and work effectively as a collaborative team player in diverse multi-disciplinary teams.

This is a fast-paced and dynamic role where you will combine the laboratory data with your strong scientific understanding of physical characterization to identify material attributes critical to robust and sustainable pharmaceutical manufacturing routes and processes. This position will play an important role in supporting development of drug substance process, long-acting injectable suspension and solution drug products.

Key responsibilities include:

• Apply material characterization knowledge to support project objectives across drug substance and drug product development.
• Identify and understand key physical material attributes that impact manufacturability, stability, and control strategy.
• Design, execute, interpret, and communicate scientific work to meet the project timelines and objectives, e.g., selection of API version and form, design and scale up of unit operations such as crystallization and isolation, formulation identification, process transfer to commercial facilities, implementation of new technology or delivery of a suitable control strategy that includes the identification of key physical materials attributes.
• Provide technical oversight of work (as necessary) performed at CROs.
• Ensure that experimental work is conducted to high standards of quality and communicated effectively at internal R&D meetings.
• Ensure appropriate scientific peer review and relevant technical oversight is in place throughout development. Identify and escalate physical drug substance and drug product risks at scientific reviews and through relevant technical and project oversight panels.
• Work closely with internal teams, external partners, CROs, CMOs, and Global Supply Chain as appropriate to support development and technology transfer activities.
• Author or contribute to regulatory submissions (including review and approval of data used therein) and approve regulatory submissions if required when delegated by the Director.
• Ensure appropriate quality and compliance activities are satisfactorily performed when executing work internally or at a CMO.
• Develop characterization strategy for projects and help identify, communicate, and escalate relevant scientific risks when needed.

Basic Qualifications:

• B.S. (+6 years of experience), MS (+4 years of experience, or PhD (+0 years of experience in Chemical Engineering, Materials Science, Pharmaceutics or related discipline.
• 3+ of experience with multiple physical and solid-state characterization techniques (such as x-ray powder diffraction, particle size techniques, rheology, thermal characterization, microscopy, micro-computed tomography) and knowledge on how to apply these to different material types.

Preferred Qualifications:

• Ph.D. in Chemical Engineering, Materials Science or related discipline.
• Experience with the physical characterization of suspension formulations.
• Experience with particle sizing of materials 0.1um-5um or with broad distributions.
• 3 + years of experience independently planning and executing experiments.
• 3 + years of experience independently analyzing and interpreting analytical data and communicating results.

Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Automation Technology, Bioprocessing, Data Analysis Tools, Drug Development, Laboratory Reports, Matrix Leadership, Method Development, Technical Problem-Solving

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.