Analytical Development Research Scientist

Vertex Pharmaceuticals•Boston, MA

3d•Onsite

About The Position

Vertex is seeking a talented individual to join our Analytical Development group in Boston, MA. As a member of an industry leading CMC team, this individual will help advance transformative medicines treating the underlying cause of serious diseases by conducting analytical chemistry activities for small molecule development programs. Responsibilities include characterization and stability assessment of drug substances, spray-dried dispersions, and drug products, as well as contributing scientifically to the resolution of broader drug development challenges in collaboration with other R&D functions. Expertise with laboratory techniques commonly used in the analysis of pharmaceutical products, including liquid chromatography (LC), is desired.

Requirements

Understanding of the drug development process, including chemical and formulation development
Skilled in HPLC, GC, KF, and broad knowledge of other techniques used in pharmaceutical analysis
Good understanding of GMP is preferred.
Hands-on GMP experience, as well as experience developing GMP friendly methods is a plus
The ability to work successfully in both a team/matrix environment as well as independently is required
The ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple activities are required
Excellent written and verbal communication skills are essential

Nice To Haves

Expertise with laboratory techniques commonly used in the analysis of pharmaceutical products, including liquid chromatography (LC), is desired.

Responsibilities

Analytical testing and data review, as well as collation, interpretation, and presentation of complex data along with recommendations to guide project decisions and new research activities
Independently designing and performing technically challenging experiments in a resourceful manner with a high degree of reliability and attention to details
Solving complex problems to support crucial project goals, as well as innovation of research methodology to address important questions enabling the advancement of development programs
Supporting method validation activities, including designing validation protocols that follow ICH and FDA guidelines and address critical factors that may not be mandated by the guidelines but are essential for validating the methods for their intended use
Representing Analytical Development on cross functional pharmaceutical development teams
Prioritizing studies, considering feasibility, timelines, and project impact
Troubleshooting and maintain general lab equipment, including LCs
Maintaining accurate records of experiments and results in an electronic laboratory notebook in a timely manner
Working collaboratively cross-functionally and within the team to achieve program goals
Complying with applicable SOPs
May supervise or mentor junior staff