Blueprint Medicines has a fantastic opportunity for a Pre-formulation Scientist to join our Formulations Sciences group within the Non-Clinical Development Sciences organization. The candidate will play a key role in the planning and execution of all activities related to the transition of novel small molecule compounds from Discovery into Development in support of Blueprint Medicines’ pre-clinical and clinical programs.
- Design, oversee and interpret characterization experiments for potential drug development candidates in collaboration with Discovery chemists.
- Manage multiple CROs to ensure execution of appropriate physicochemical characterization to enable drug substance form and development candidate selection, including overseeing and interpreting polymorph and salt screening.
- Support phase-appropriate formulation development to enable non-GLP and GLP pre-clinical studies, as well as inform clinical development.
- Monitor drug substance and formulation stability studies to ensure optimal formulation development and selection.
- Collaborate with DMPK, Toxicology and Drug Safety colleagues to facilitate appropriate formulation selection and support for non-clinical studies.
- Manage and coordinate formulation transfer and preparation activities at CRO for non-clinical studies.
- Contribute to initial bulk characterization activities to support Phase I development for solid oral dosage forms.
- Support late stage product optimization through appropriate characterization activities.
- Coordinate and collaborate with Discovery, Analytical Development, Process Chemistry and Formulations to monitor and plan appropriately to support the advancement of molecules.
- Represent preformulation sciences on internal and CRO project teams.
- Author and review regulatory documents.
- Establish and maintain effective working relationships with key internal and external stakeholders.
- B.S degree in pharmaceutics, chemical engineering or material sciences with 5-8 years or PhD with 1-2 years as a team member of various drug development programs.
- Experience overseeing and interpreting polymorph and salt screening is required.
- Knowledge of small molecule and solid oral dosage forms is required.
- Experience in the Discovery and Development interface.
- Experience managing relationships with CROs and testing labs.
- Understanding of the physical and chemical characterization of molecules, including solid state and solution properties.
- Experience with technologies to enhance poorly soluble and/or bioavailable candidates and the physical and chemical characterization of molecules
- Ability to effectively prioritize and manage multiple projects and tasks
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A team player, who listens effectively and invites response and discussion
- A collaborator who communicates in an open, clear, complete, timely and consistent manner