Formulation Senior Research Scientist

Vertex Pharmaceuticals • Boston, MA

95d • $120,300 - $180,400

About The Position

The Formulation Senior 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. This role designs and executes elaborate experiments for pharmaceutical sciences projects and demonstrates resourcefulness in running multiple activities concurrently, all related to achievement of goals/objectives.

Requirements

• 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, verbal and written communication skills
• Successful and efficient multitasking and working on a few projects concurrently
• Detail-oriented
• Strong background in physical chemistry and good understanding of material properties
• Broad perspective and a deep knowledge of related disciplines and possesses diverse project experience and a broad knowledge of relevant literature and regulatory compliance
• Direct experience working with CMOs is a plus
• 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
• A history of success working in environments defined by innovation and initiative
• Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
• Excellent leadership, teamwork and organizational skills
• Solid verbal and written communication skills
• GLP, GMP and GxP experience
• Strong data analysis skills
• Willingness to travel as needed

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.)
• Designs and performs technically challenging experiments in compliance with applicable regulations and SOPs
• Interprets moderately complicated, multidimensional data and makes recommendations on new processes and development directions
• Performs relatively advanced experimental troubleshooting and methods development
• Multi-tasks to effectively manage efforts on multiple activities and/or projects
• Scours relevant scientific literature within field and surveys broadly beyond own discipline/field
• May innovate technical methodologies to improve outcomes and achieve results
• Contributes to patent and publication preparation
• Imports new principles/concepts from other fields to develop useful new experimental approaches
• May be the practical manager of CRO contracts or external collaborative development
• May supervise other Pharmaceutical Operations staff and may be responsible for quality, timeliness and accuracy of work done of others

Benefits

• Medical, dental and vision benefits
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k)
• Annual bonus and annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree