Senior Research Associate - Formulations

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We are looking for a Senior Research Associate in Pharmaceutical Development & Formulations for a direct hire position at a leading biotechnology/pharmaceutical company.

 

ResponsibilitiesDesign and coordinate experimental activities based upon empirical and statistical design of experiments to determine the effect of formulation and process variables on product performance.  Analyze and interpret data, and provide feedback based upon experimental results and processing/testing observations.Independently and skillfully operate processing equipment typically employed during solid and liquid dosage form manufacturing.Utilize equipment specific software for enhanced data capture and analysis from processing equipment and analytical instrumentation. Conduct physical and chemical testing of raw materials, process intermediates and finished dosage forms.Identify experimental variables critical to product performance and define operating regions (process windows) that support subsequent scale up and technology transfer activities.  Troubleshoot and successfully resolve technical issues related to formulations and processes.Maintain a laboratory notebook for the purpose of recording reproducible, accurate and complete descriptions of experimental procedures and results.Provide leadership in the technology transfer of CMC information between internal departments and external R&D and commercial manufacturing sites.Assume primary responsibility for the preparation of research memorandums, study reports and related CMC documentation to support regulatory filings.Provide leadership in the development and successful implementation of procedures that promote safe working condition within the laboratory and process environment.

Qualifications

Candidates will have a minimum of a  BS or MS degree in a science or engineering with 4-7 years experience in formulation and/or process development in the pharmaceutical industry.  Candidates will also have:

· Strong technical and functional understanding of process equipment utilized in the manufacture of pharmaceutical dosage forms.

· Working knowledge of materials assessment and fluid/powder mechanical properties that impact the performance and manufacture of pharmaceutical dosage forms.

· Familiarity with procedures for the safe handling of hazardous materials utilizing state-of-the-art personal protective equipment and engineering controls.

· Working knowledge of cGMP regulations and their application in a clinical and/or commercial manufacturing setting.

 



If you would to be considered for this opportunity, send a copy of your resume to recruit@astrixtechgroup.com with Sr. RA -Formulations in the subject line.