As Scientist, Preformulation, the employee will design and execute preformulation and physical characterization studies to support product development from early discovery through commercialization. Fully characterize API and Drug Product (DP) materials to inform development decisions for Research, Preformulation, Chemistry, and Formulation. Support preclinical development by formulating optimized toxicology vehicles and providing in-use stability data as needed. Establish 3rd party relationships to outsource key development activities to meet timelines between Preclinical and Clinical. Represent Product Development within early-phase project teams to support selection of a developable API form utilizing salt/polymorph-screening & selection along with other Preformulation characterization studies.
Primary Duties and Responsibilities
- Lead weekly or bi-weekly NBI-CMO project team meetings and inform both up and down the chain of command as to progress, resource gaps and timelines
- Characterize API and DP materials via DSC, TGA, PXRD, GVS, PLM, and SEM
- Execute thermodynamic and biorelevant kinetic solubility studies for potential lead drug development candidates
- Evaluate and map powder properties and physical characteristics of API and DP to de-risk later stage DP manufacturing operations.
- Source, procure, install, qualify, operate, and maintain instrumentation and equipment required for Preformulation activities as needed
- Collaborate with Discovery, Chemistry, Analytical, and Product Development; bridging communications between departments and ensuring conclusions from data generated are applied correctly and used widely and effectively
- Assemble and maintain Preformulation documentation repository to allow efficient retrieval of development reports, protocols, memos, specifications, and other relevant documentation
- BS in chemistry or closely related field; Minimum of 4 years relevant industrial experience in an R&D/QC setting (MS with 2-4 years)
- Proficient using MS-Excel, MS-Word as well as data systems for computer controlled instrumentation
- Significant practical experience conducting HPLC analysis and troubleshooting.
- Significant experience evaluating analytical data and drawing meaningful conclusions
- Knowledge of cGMP expectations for laboratory records and quality systems
- Strong attention to detail, excellent written and oral communication skills
- Ability to provide ideas for process improvements
- Ability to work with a team of individuals to meet goals
- Experience working in a timeline driven setting