Summary: The Senior/Principal Scientist in Pre/Early Formulation Development will develop formulations to support preclinical and Phase I studies including PK, PD, efficacy, tox studies as well as first-in-human.
Lead development activities in phase-appropriate solid form selection and physicochemical characterization, such as powder X-ray diffraction, DSC, TGA, SEM, particle size, polarized light microscopy, moisture sorption analysis, solubility, dissolution and stability assessments.
Designs experiments, strategies and workflows to improve bioavailability of poorly soluble drug molecules through enabling technologies.
MS or PhD in Chemistry, Pharmaceutical Science or related field.
At least three years of experience in pre-/early formulation development (solution, suspension, tablet, capsule, etc).
Good understanding of solid-state chemistry of small molecule drug substances.
Working knowledge of analytical techniques such as PXRD, TGA, DSC, PLM, DVS, HPLC, NMR and PSD.
Experience within the pharmaceutical/biotechnology industry or CDMO industry is required. Experience in both is desirable, but not required.
Proven track record meeting aggressive targets as related to safe, timely and successful projects.
Knowledge and experience base of working in a c-GMP environment is preferable, but not required
Excellent written, verbal and presentation skills.
Strong communication, organization, and planning skills.
Experience in small molecule drug development is preferable, but not required.
Track record of scientific success as measured by publications and presentations.
Ability to prioritize and manage numerous activities simultaneously.
Ability to interact in an effective and appropriate manner with diverse population sets.
Experience in working on and positively contributing to scientific teams.
Ability to perform the physical requirements of the position.