Seeking a scientific leader to conduct pre-clinical formulation activities in support of the company's long term therapeutic strategy. This is a huge developmental opportunity for long term growth as you will have the opportunity to collaborate corss functionally and manage other external CMC activities as projects advance to clinical trials.
- Collaborate with Medicinal Chemistry, CMC, Biology, DMPK, and Pharmacology.
- Oversee pre-clinical formulation development strategies and activities, as well as solid-state characterization of lead compounds.
- Increase output of amorphous solid dispersion (ASD) and formulation prototypes.
- Develop formulation prototypes for pre-clinical pharmacokinetic, pharmacology, and toxicology studies.
- Create small to medium scale formulations for in vivo studies.
- Oversee outsourced characterization, pre-formulation, and drug-product development activities as needed.
- Add new technologies and methodologies as needed.
- Draft study reports and regulatory filings
- M.S. in Pharmaceutical Science or a related field with 5+ years of experience, or Ph.D. in Pharmaceutical Science or a related field with 1-2 years of experience in drug discovery and early development activities.
- Expertise with spray dried dispersions or hot melt extrusions is highly desired.
- familiarity in HPLC, LC/MS, UV-Vis, DSC, TGA, PLM, XPRD, SEM, FTIR, dissolution testing, and particle size analysis.
- Understanding of DMPK, physicochemical, biochemical, and pharmacological principles, as well as prior application success
- Excellent oral and written communication skills
- Ability to work well in multidisciplinary teams and learn new skills