Principal Scientist, Formulation- Dissolution

Job Description

General Summary:

Vertex Pharmaceuticals is seeking a talented scientist who can provide project leadership to join our Formulation Development group in Boston, MA. Consistently and passionately challenging the boundaries of their knowledge, our Formulation Development team employs traditional and innovative techniques and Quality-by-Design principles to ensure the safety, efficacy, and quality of Vertex pharmaceutical products.

As a member of the Formulation Development team, this scientist will support the drug development programs at Vertex through phase appropriate dissolution method development, validation, and transfer. The ideal candidate will have proven ability to learn quickly, communicate effectively and deliver results in a fast-paced environment.  This person will have the opportunity to provide project leadership on early and late stage development projects by developing analytical strategies for phase appropriate dissolution methods and specification justifications.  Applicants should understand drug product processing, drug substance physical form, dissolution testing, and biopharmaceutical modeling.  Vast knowledge of guidelines and associated recommendations is a must (ICH, USP, etc).  Strong analytical technical capabilities, formulation development knowledge and excellent communication skills are required to be successful in this role.

Key Duties and Responsibilities:

• Justification of clinically relevant dissolution method parameters and specifications

• Understanding of biorelevant media testing and its applications

• Understanding how drug substance physical form, solubility, and drug product processing can impact analytical methods and specifications

• Understanding of key analytical deliverables for late stage programs including method development, validation, specification setting, stability, release testing and analytical strategies to bring these individual items together collectively for a fast-paced program

• Authoring dissolution sections for regulatory submissions

• Designing validation protocols that are in compliance with ICH and FDA guidelines

• Identifying critical factors/parameters that may not be mandated by guidelines but are essential for developing a robust method and validating it for its intended use

• Communicating risk and mitigation plans

• Mentoring, training, and developing junior colleagues while working in a matrix team environment

• Authoring methods, protocols and reports as assigned

• Reviewing results to support multiple projects in parallel

• Independently designing and performing elaborate, technically challenging experiments in a resourceful manner with a high degree of reliability and attention to details

• Performing basic statistical analysis of experimental data, where appropriate

• Demonstrating knowledge of scientific principles and basic understanding of applicable drug development regulations

• Generating effective hypotheses to pursue project goals and set new experimental directions

• Identifying broad implications of results and their impact on overall study

• Developing novel and creative solutions to overcome project goal obstacles

• Helping to oversee dissolution system maintenance and troubleshooting

Knowledge and Skills:

• Experience developing and authoring method justification reports, establishing specifications, and authoring justification of specifications, marketing applications and responses to information requests from regulatory agencies

• Attention to detail and ability to track key information across programs

• A thorough understanding of developing and defending clinically relevant dissolution specifications

• Knowledge of various dissolution systems and apparatus types

• Excellent attention to detail and strong communication and documentation skills

• The ability to work successfully in both a team/matrix environment as well as independently

• The ability to work in a fast pace environment, manage priorities, communicate outcomes and maintain timelines for multiple projects

• Leadership experience, but not necessarily management experience, is required

Education and Experience:

• Typically requires a PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 4-7 years experience in life sciences, engineering or academia, or

• Typically requires a Master's Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 7 year