Contract - Scientist I - Formulation/Pharmaceutical Development

CONTRACT - SCIENTIST I - FORMULATION / PHARMACEUTICAL DEVELOPMENT

Position Summary:

Scientist I/II - Formulation/Pharmaceutical Development will help conduct pre-formulation, formulation development, tech transfer and manufacturing activities with the goal of developing robust oral formulations for preclinical and early phase clinical programs.

Essential Duties and Responsibilities:

• Perform pre-formulation studies such as physico-chemical characterization, pH solubility, excipient compatibility studies etc. and interpret data
• Develop HPLC analytical methods for early phase programs and execute early phase stability studies for toxicology formulations
• Design and conduct pre-clinical/toxicology/clinical formulation development activities for various dosage forms
• Support the pharmaceutical development team with clinical phase drug product formulation development, tech transfer to CMO and GMP manufacturing
• Manufacture solid dose formulations and characterization using bulk/tap density, hardness, thickness, friability, disintegration and dissolution profiles at GBT
• Execute statistical design of experiments (DoE) studies to evaluate formulations and process
• Manage, set up and maintain all the equipment in the formulation lab
• Maintain inventory of supplies, chemicals and excipients needed for the formulation lab
• Perform tasks per protocols and develop new protocols as needed
• Draft reports and present results to colleagues. Other Duties as assigned
• Approximately 10 - 20% travel may be needed for scientific project management and monitoring of critical project activities

Qualifications:

• MS with 3-9 years or Ph.D. with 2 - 5 years of experience in pharmaceutical sciences, chemistry, chemical engineering, or related discipline
• Absolutely require hands-on laboratory experience in pre-formulation, solid-state/physico-chemical, thermal characterization
• Experience in pharmaceutical unit operations (tablet/capsule granulations, milling, tablet compression, tablet coating etc.)
• Experience with formulation development of therapeutic agents
• Independent problem-solving and troubleshooting abilities
• Excellent data analysis skills with attention to detail and interpretation of results
• Excellent oral and written communication skills
• Demonstrated track record of completion of development reports
• Ability to work independently and in a team environment