The Molecular Profiling and Drug Delivery (MPDD) function within the Small Molecule CMC organization is accountable for a broad range of deliverables across various stages of drug discovery and development. During lead optimization and through candidate selection, MPDD scientists utilize state-of-the-art automation and computational tools supported by expertise in biopharmaceutics, drug delivery, and solid-state chemistry to collaboratively progress candidates with higher probability of success into development and advise clinical formulation strategy. From candidate selection through clinical proof of concept and product launch, MPDD scientists work in cross functional teams to identify the commercial solid form of the active pharmaceutical ingredient (API) and establish structure-property-performance correlations to help deliver robust commercial processes and align control strategies across drug substance and product. They also collaboratively transition drug substance isolation processes and relevant physical characterization methods to commercial manufacturing sites and work within teams to ensure successful regulatory submissions.

Responsibilities

• Lead identification and development of solid forms of synthetic drug substances for robust manufacturing processes and products, supporting assets through all phases of development. 
• Develop and implement state-of-the-art computational tools to map and de-risk solid form landscape.
• Establish and utilize a diverse array of solid state and materials science characterization techniques, incorporating automation and modeling tools, to define the structure–property–performance relationships of pharmaceutical products.
• Collaboratively develop manufacturing processes in the laboratory and demonstrate the processes in the pilot plant to enable clinical supplies.
• Set project strategies, define project responsibilities and timelines, and provide leadership in a matrixed team setting. Establish, communicate, and execute research plans.
• Supervise and mentor junior scientists and interns, fostering technical and professional growth.
• Publish research findings and represent the organization as a thought leader at scientific conferences.