Formulation Sr Research Associate

JOB DESCRIPTION:

Title: Formulation Sr Research Associate

Location: Boston, MA

Duration: 6m+

·lyophilization equipment experience required

·Master’s degree plus 1 or 2 years’ experience

·70% lab 30% desk

Key Duties and Responsibilities:

• Timely document integrated experimental outcomes in presentations and research reports
• Maintain accurate and complete laboratory notebook capturing protocols, results and observations
• Interpret data to form sound conclusions
• Assist in technical transfer to CMO partners for clinical trial manufacture
• Perform basic statistical analysis of experimental data
• 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
• Comply with all relevant Safety and GMP procedures
• Contribute to drafting regulatory filing documentation
• Initiate experimental troubleshooting on routine problems, with minimal supervision
• Help execute, and interpret laboratory experiments, with minimal supervision, to meet established project timelines

Knowledge and Skills:

• Understanding of QbD and experience with Regulatory filings is a plus
• Strong verbal and written communication skills
• Strong math skills particularly as applied to material/energy balances, and intermediate applied statistical analysis
• Detail-oriented
• Hands on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales
• Sound technical knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
• Strong background in oral solid form development and good understanding of material properties
• Strong technical writing skills
• Direct experience working with CMOs is a plus
• Successful and efficient multitasking and ability to work on a few projects concurrently

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,