The Formulation Principal 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.
This is a 6 month contract role.
40 hours per week.
M-F normal business hours.
Key Duties & Responsibilities
• Develop solid dosage forms for clinical and commercial use, generate data for project progression
and regulatory filings, conduct optimization and scale up studies.
• Help design, plan, 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 a routine basis, with minimal supervision
• Contribute to drafting regulatory filing documentation
• Comply with all relevant Safety and GMP procedures
Required Education Level
• Masters Degree (or equivalent degree) in a related physical sciences and 0-2 years of relevant employment experience
or
• Bachelors Degree (or equivalent degree) in a related physical science sciences and 5+ years of relevant employment experience
Required Knowledge/Skills
• Sound 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
• Excellent verbal and written communication skills
• Successful and efficient multitasking and working on a few projects concurrently
• Detail-oriented
• Knowledge of QbD
• The ability to work successfully in a team/matrix environment
• The ability to work in a fast paced environment, manage priorities, and maintain timelines for multiple projects
dependent upon experience. $35 - $42/HR
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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