Senior Scientist: SEC, icIEF & Impurity (Onsite)

ThermoFisher Scientific; Boston (MA); On-site; USD 95,000 - 100,000; Full time

Benefits offered by this job

Medical plans

Vision plan

Paid time off (PTO) 120 hours+

401(k) plan with company match

EspP stock purchase

Job summary

Thermo Fisher Scientific in Massachusetts seeks a Senior Scientist for SEC/icIEF/Impurity work to lead analytical methods development and transfer in a GMP setting. The role is fully onsite in Boston, with standard day shifts and responsibilities across method validation, lifecycle management, and regulatory support.

The ideal candidate will hold a Bachelor's or higher in a lab science, 2–4+ years of relevant experience, strong writing and collaboration skills, and the ability to operate within

Qualifications

• Experience in analytical method development, validation, transfer and lifecycle management for biologics or related products.
• Strong knowledge of GMP requirements and regulatory guidance for late-stage and commercial products.
• Excellent scientific writing and data interpretation abilities; ability to compile regulatory documentation.

Responsibilities

• Support technical transfer, validation, remediation and impurity assays for biologics (LC, SEC, icIEF, CE-SDS).
• Author, review and approve technical protocols, reports and lifecycle documents.
• Develop transfer study designs, testing plans and acceptance criteria.
• Manage critical reagents, reference standards and supply continuity.
• Support investigations, CAPAs, OOS/OOT and risk assessments.
• Provide analytical content for regulatory submissions and inspection readiness.

Skills

Method development

Transfer

Regulatory knowledge

Data analysis

Technical writing

Education

Bachelor's degree in lab sciences

Sr. Scientist experience (4+ years)

Masters degree (2+ years)

PhD

Tools

JMP

Job description

Thermo Fisher Scientific in Massachusetts seeks a Senior Scientist for SEC/icIEF/Impurity work to lead analytical methods development and transfer in a GMP setting. The role is fully onsite in Boston, with standard day shifts and responsibilities across method validation, lifecycle management, and regulatory support.

The ideal candidate will hold a Bachelor's or higher in a lab science, 2–4+ years of relevant experience, strong writing and collaboration skills, and the ability to operate within