Principal Scientist, Material Characterization

GSK•Upper Providence, PA

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.