Scientist for Drug Product Development
San Diego Metro Area, CA
1. Provides direct on-site formulation support to enable efficacy, PK, and toxicology studies for San Diego based discovery groups
2. Conducts drug substance physicochemical characterization of NEC s to evaluate the risk in development of small molecules
3. Develop chromatography-based methods for assaying small molecule content, related impurities, and degradation products. Experiences with chiral LC method development is desired. Must have experience with Waters UPLC and Empower software.
4. Conducts solubilization enhancement studies, and supports enabled formulation development (amorphous solid dispersion, Nano formulation, lipid-based formulation) to improve exposure in the preclinical species
5. Conduct preliminary salt and polymorph screening
6. Maintain equipment, interface with equipment vendors and troubleshoot problems when they occur
7. Interface with Discovery team members to design, schedule and execute experiments.
8. Strong interpersonal, communication, collaboration and problem-solving skills.
9. Ability to document work in electronic notebooks, presentations, reports and procedures.
The successful candidate will conduct hands-on laboratory work such as solubility, stability, formulation development for preclinical animal species, solid state characterization, and preliminary salt/polymorph screening to inform the risk in pharmaceutical development of small molecules. Formulation development includes vehicle screening, small scale screening for amorphous solid dispersion and nanosuspensions. Characterization work includes HPLC/MS, XRD, TGA, DSC, and DLS. The scientist will collaborate with Discovery team in San Diego and Development team in Summit, NJ. The scientist will participate in the departmental meeting and present on their work on a regular basis. This is a hands-on, laboratory-based role in a highly collaborative early development environment.
B.S. or M.S. in Chemistry, Pharmaceutical Sciences, or related scientific discipline.
Must have experiences in the pharmaceutical industry in discovery support, and preformulation.
Advanced degree preferred.