Senior Principal Scientist, Drug Substance Analytics

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

Benefits offered by this job

Annual bonus

Equity awards

Medical benefits

Dental benefits

Vision benefits

Paid time off

401(k)

Job summary

Vertex is seeking an experienced scientist to help develop analytical control strategies for small molecule drug substances across clinical and commercial‑enabling phases. You will collaborate with CMC functions and external vendors to design and execute studies that inform overall control strategy.

The role requires a Ph.D. with extensive analytical development experience, strong knowledge of regulatory guidelines, and the ability to communicate technical results to cross‑functional teams.

Qualifications

• Ph.D. with 4+ years of analytical development experience; exceptions for MS with 7+ years or BS with 10+ years.
• Background in modern synthetic organic chemistry and drug substance development, process chemistry, and manufacturing.

Responsibilities

• Collaboratively design and oversee drug substance process development analytical activities across all development phases.
• Set and justify drug substance, intermediates, and starting materials specifications with regulatory alignment.
• Identify critical in-process-control issues and develop IPC methods.
• Act as SME for drug substance analytics with contract labs and manufacturers.
• Develop analytical methods for progressive stages of development.
• Justify retest periods, storage, and shipping conditions for starting materials and intermediates.
• Document factors affecting quality and method performance for regulatory submissions.
• Present to cross-functional teams and communicate analytical issues and solutions.

Skills

Excellent verbal and written comms

Control strategy development

QbD process development

Regulatory guidelines (ICh/FDA/USP)

Chromatography

Team collaboration

Fast-paced environment

Education

Ph.D.

MS degree

BS degree

Tools

HPLC

Job description

Vertex is seeking an experienced scientist to help develop analytical control strategies for small molecule drug substances across clinical and commercial‑enabling phases. You will collaborate with CMC functions and external vendors to design and execute studies that inform overall control strategy.

The role requires a Ph.D. with extensive analytical development experience, strong knowledge of regulatory guidelines, and the ability to communicate technical results to cross‑functional teams.