Senior Scientist, Separation Methods for Biologics

Vertex Inc.; Boston (MA); Hybrid; USD 138,000 - 208,000; Full time

Job summary

Vertex Inc. seeks an Analytical Science and Technology Principal Scientist, Separation Method Expert, to lead method remediation, validation and transfer for late-stage and commercial biologics.

The role collaborates with internal teams and contract testing sites to ensure cGMP compliance and robust analytical readiness across the global network. Responsibilities include owning change controls, investigations, data trending, regulatory support for INDs/BLAs, and authoring SOPs and validation

Qualifications

• PhD/Master’s/Bachelor’s with 5+ / 8+ / 10+ years of relevant experience respectively.
• Expertise in analytical method lifecycle for biologics.
• Familiarity with GMP, ICH, USP/EP/JP guidance as applied to analytical methods.

Responsibilities

• Lead method remediation, validation and transfer for separation methods in late-stage and commercial programs.
• Lead troubleshooting and investigations for in-process, release and stability testing.
• Own quality events and analytical activities (Change Controls, Impact Assessments, Change Actions).
• Author technical documents (SOPs, validation reports, risk assessments) and support regulatory submissions.

Skills

Analytical method development

Method validation

Method transfer

Chromatography

Protein/biologics knowledge

Regulatory knowledge (ICH/USP)

Statistics ( JMP )

Technical writing

Education

PhD in Biochemistry/ Chemical Engineering

Master’s in related field

Bachelor’s in related field

Tools

HPLC/UPLC

Mass spectrometry

CE/IEF equipment

Job description

Vertex Inc. seeks an Analytical Science and Technology Principal Scientist, Separation Method Expert, to lead method remediation, validation and transfer for late-stage and commercial biologics.

The role collaborates with internal teams and contract testing sites to ensure cGMP compliance and robust analytical readiness across the global network. Responsibilities include owning change controls, investigations, data trending, regulatory support for INDs/BLAs, and authoring SOPs and validation