Formulation Senior Research Associate
50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
Job Description
General Summary:
The Formulation Senior Research Associate will perform an array of activities working with other scientists to advance drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools.
Key Duties and Responsibilities:
· Contribute to the development of solid dosage forms for clinical and commercial use, generate data for project progression and regulatory filings, conduct a range of activities for optimization and scale up studies
· Help execute, and interpret laboratory experiments, with minimal supervision, to meet established project timelines
· Maintain accurate and complete laboratory notebook capturing protocols, results and observations
· Interpret data to form sound conclusions
· Timely document integrated experimental outcomes in presentations and research reports
· Perform basic statistical analysis of experimental data
· Assist in technical transfer to CMO partners for clinical trial manufacture
· Initiate experimental troubleshooting on routine problems, with minimal supervision
· Contribute to drafting regulatory filing documentation
· Comply with all relevant Safety and GMP procedures
Knowledge and Skills:
· Sound technical knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
· Hands on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales
· Strong math skills particularly as applied to material/energy balances, and intermediate applied statistical analysis
· Strong technical writing skills
· Strong verbal and written communication skills
· Successful and efficient multitasking and ability to work on a few projects concurrently
· Detail-oriented
· Direct experience working with CMOs is a plus
· Understanding of QbD and experience with Regulatory filings is a plus
· Strong background in oral solid form development and good understanding of material properties
Education and Experience:
· Typically requires a Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0-2 years experience in life sciences, engineering or academia
Pay Rate Range: $36-40
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