CONTRACT – SENIOR RESEARCH ASSOCIATE – FORMULATION /PHARMACEUTIAL DEVELOPMENT
Position Summary:
Senior Research Associate – 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 physio-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
- 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
Qualifications:
- BS with 5 – 9 years or MS with 3 – 5 years of experience in pharmaceutical sciences, chemistry, chemical engineering, or related discipline
- Require hands-on laboratory experience in pre-formulation, solid-state/physio-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