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Job Description

General Summary:

The Formulation Research Scientist will work with other scientists dedicated to advancing drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools to design and select dosage forms and manufacturing process.

Key Duties and Responsibilities:

• Develop dosage forms for clinical and commercial use

• Develop stable and bioavailable formulations for different stages of development (e.g., solution/suspension based formulations, amorphous pharmaceutical systems into solid oral dosage forms, parenterals, etc.)

• Help to design, execute experiments and analyze, and present results

• Generate data for project progression and regulatory filings, conduct optimization and process scale up studies

• Maintain accurate and complete laboratory notebook capturing protocols, results and observations

• Interpret data to form sound conclusions and perform experimental troubleshooting on a routine basis

• Perform basic statistical analysis of experimental data

• Timely document integrated experimental outcomes in presentations and research reports

• Transfer of technical knowledge to contract research sites (CRO) for onsite clinical preparations

• Oversight of outsourcing activities such as scale-up and technology transfer to contract manufacturing sites (CMO) partners for clinical trial manufacture externally as well as support clinical trial material manufacture within Vertex

• Coordination with other Vertex groups (such as Analytical Development, Materials Discovery and Characterization, Supply Chain Management, Quality Assurance, etc.) to ensure that Clinical Trial Materials are produced in a timely manner

• Contribute to drafting regulatory filing documentation

• Comply with all relevant Safety and GMP procedures

Knowledge and Skills:

• Strong critical thinking skills

• Ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to technical problems, using a rational, scientific approach

• Strong technical writing and data analysis skills

• Excellent verbal and written communication skills

• Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines

• Excellent teamwork and organizational skills

Education and Experience:

• PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0+ years experience in life sciences, engineering or academia, or

• Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 3+ years experience in life sciences, engineering or academia, or

• Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 6+ years experience in life sciences, engineering or academia

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