Analytical Science and Technology Senior Scientist

Vertex Pharmaceuticals•Boston, MA

2d•Hybrid

About The Position

Vertex is seeking a highly motivated and experienced Senior Scientist to join the Analytical Science and Technology team. In this role, you will work closely with contract manufacturing organizations and a diverse, cross-functional group of scientists at Vertex to solve complex challenges encountered during late-stage development and commercial manufacturing of small-molecule drug products. The ideal candidate will have a strong scientific foundation and a proven track record of developing, implementing, and troubleshooting analytical methods within the pharmaceutical industry. This individual should thrive in a fast-paced environment and demonstrate the ability to collaborate effectively across cross-functional teams, communicate clearly, and drive solutions to support product development and commercial success.

Requirements

Strong practical analytical chemistry skills across a range of general analytical techniques that must include (U)HPLC and GC
Proven experience in analytical development or technical operations, supporting late-stage development, commercialization and post-approval activities
Demonstrated expertise in problem-solving and root cause analysis for analytical related issues
Strong technical knowledge of chromatographic methods, including HPLC, GC, and other analytical techniques commonly used in pharmaceutical analysis
Experience applying compendial methods such as KF, elemental impurity testing, spectroscopic identification)
Solid understanding of cGMP regulations, ICH guidelines and CMC regulatory expectations in a pharmaceutical setting
Proficiency in data analysis, trending and visualization tools to support decision-making and process monitoring
Strong communication, collaboration and technical writing skills
Proven ability to work successfully in a fast-paced, matrixed environment while also operating independently with minimal supervision
Strong project management skills and the flexibility to adjust to shifting project priorities and business needs

Responsibilities

Designs and performs elaborate and technically challenging analytical experiments in compliance with applicable regulations and SOPs
Lead analytical method transfer activities for small molecule drug product to CMOs or between internal groups
Support method validation or co-validation activities for late-phase development and commercial programs
Prepare, review, and approve technical documentation for commercial products, including analytical methods, SOPs, transfer protocols and reports, laboratory records, and technical reports.
Serve as the primary analytical lead for external CMOs, overseeing analytical service execution, driving investigations, and partnering on process-related issue resolution
Analyze and trend commercial data to support continued process verification, identify emerging issues, and inform data-driven decisions.
Support product lifecycle management activities and implement continuous process improvement through commercial change control