Principal Scientist - Drug Substance Analytics & Control

Vertex Pharmaceuticals; Boston (MA); On-site; USD 141,000 - 211,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Paid time off

Educational assistance

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex Pharmaceuticals is seeking an experienced scientist to help develop cutting-edge small molecules and the analytical control of their syntheses. As a member of the Drug Substance Control Strategy team in Analytical Development, this role will support synthetic drug development programs across clinical and commercial-enabling phases, focusing on process and control strategy development.

The successful candidate will oversee experiments, collaborate with CMC functions, and liaise with

Qualifications

• PhD with 4+ years in analytical development for small molecules.
• MS with 7+ years of experience in analytical development; BS with 10+ years considered.
• Understanding of drug substance development, process chemistry, and regulatory guidelines (ICH/FDA).

Responsibilities

• Design and oversee drug substance analytical activities across development phases.
• Set and justify drug substance specifications with regulatory alignment.
• Identify IPC issues and develop IPC methods.
• Collaborate with contract manufacturing and testing labs.
• Develop analytical methods for progression stages.
• Document factors impacting quality and method performance.
• Prepare source documents for regulatory submissions.
• Present analytical findings to cross-functional teams.

Skills

Analytical development

QbD process development

cGMP/ICH/FDA knowledge

Chromatography

Cross-functional collaboration

Communication skills

Education

PhD with analytical development focus

MS with analytical development focus

BS with chemistry background

Job description

Vertex Pharmaceuticals is seeking an experienced scientist to help develop cutting-edge small molecules and the analytical control of their syntheses. As a member of the Drug Substance Control Strategy team in Analytical Development, this role will support synthetic drug development programs across clinical and commercial-enabling phases, focusing on process and control strategy development.

The successful candidate will oversee experiments, collaborate with CMC functions, and liaise with