Formulation Research Scientist

Role Summary

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.

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, 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

• Expanded conceptual 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 and data analysis skills
• Excellent verbal and written communication skills
• Strong background in physical chemistry and good understanding of material properties
• Understanding of QbD and experience with regulatory filings is a plus
• Experience working with small molecule new chemical entities (NCEs) and exposure to early phase formulation development activities
• Experience with a range of dosage forms, including liquids, solids and oral. Experience with formulation development of poorly soluble compounds would be advantageous
• Proven experience managing the scale-up and manufacturing of solid oral dosage forms
• Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to preformulation and formulation development, using a rational, scientific approach
• Ability to work effectively and comfortably in a multi-disciplinary team under defined timeline
• Excellent teamwork and organizational skills
• GLP, GMP and GxP experience

Education

• PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 0-3 years of experience in life sciences, engineering or academia
• Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 3+ years of experience in life sciences, engineering or academia
• Bachelor's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 6+ years of experience in life sciences, engineering or academia