Responsibilities will include, but are not limited to, the following:
The Scientist I position will be responsible for the development and validation of methodology for physical characterization of pharmaceutical solids, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development. Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.
The Scientist I individual should work with minimal supervision to carry out laboratory based physical and chemical characterization studies, method development, and stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
 Support crystalline form or polymorph identification in drug substance and drug product.
 Develop, optimize and validate physical characterization methods, such as XRPD, DSC, TGA, DVS, IR, Raman, microscopy, surface area, and particle size analysis.
 Qualify/transfer analytical methodology to quality control and contract laboratories.
 Generate physical characterization data for clinical release and stability studies.
 Carry out polymorph screen studies for new drug candidates.
 Serve on and lead departmental, interdepartmental and project teams.
 Report and discuss analytical results and conclusions both orally and in writing.
 Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
 Adhere to all relevant compliance requirements.

Qualifications
Prerequisite:
Completed Ph.D. in Chemistry (or relevant discipline) with post-doctoral research experience; or
Completed Ph.D. in Chemistry (or relevant discipline); or
Completed MS in Chemistry (or relevant discipline) and minimum of 5 years of pharmaceutical laboratory experience required; or
Completed BS in Chemistry (or relevant discipline) and minimum of 8 years of pharmaceutical laboratory experience required

Skills/Knowledge required:
 Academic background in Physical Chemistry or an allied chemistry discipline (e.g. Analytical, Organic) with demonstrated analytical capabilities.
 Comprehensive knowledge of chemistry with extensive expertise in measurement science.
 A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
 Laboratory experience with and an in-depth knowledge of conventional physical characterization techniques such as XRPD, DSC, IR, and microscopy is a must.
 Strong problem-solving and troubleshooting skills.
 Strong capabilities in experimental design and execution.
 Ability to work independently.
 Strong verbal and written communication skills.
 Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
 Ability to provide scientific guidance, leadership and training to others within the department

Skills/Knowledge in the following areas are a plus:
 Familiarity with drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences.
 Strong statistical knowledge and capabilities.
 Advanced skills in DOE, Lean and/or Six Sigma.
 Knowledge of particle size analysis by laser diffraction and image analysis.
 Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance.
 Familiarity with the USP and other compendia.