CMC Technical Writer - Late-Stage Lipids (Hybrid)

Eurofins PSS Insourcing Solutions; Boston (MA); Hybrid; USD 55,000 - 68,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Bonus merit increases

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a CMC Technical Writer to support late-stage Lipids transfer and process chemistry. You will craft clear, technically rigorous reports from CDMOs, translating data into executable narratives for regulatory readiness and knowledge management.

The role requires a solid chemistry/engineering background, strong English communication, and experience with cGMP documentation.

Qualifications

• B.S./M.S./PhD in chemistry, engineering, or related field with industry process chemistry/synthetic experience.

Responsibilities

• Draft conclusion-driven process development reports from objectives and SME input.
• Structure reports per internal templates and late-stage CMC standards.
• Translate raw data into tables, figures, and summaries without SME pre-work.
• Produce substantial first drafts with minimal SME revision.
• Maintain traceable, inspection-ready documentation for regulatory submissions.
• Collaborate across process development to align reporting and packages.

Skills

Technical writing

Written and verbal communication

Attention to detail

Interpersonal collaboration

Self-motivation

Time management

Education

B.S. in chemistry/engineering

M.S. in chemistry/engineering

PhD in chemistry/engineering

Tools

MS Word

Excel

EDMS platforms (Veeva Vault, Documentum)

Job description

Eurofins USA PSS Insourcing Solutions is seeking a CMC Technical Writer to support late-stage Lipids transfer and process chemistry. You will craft clear, technically rigorous reports from CDMOs, translating data into executable narratives for regulatory readiness and knowledge management.

The role requires a solid chemistry/engineering background, strong English communication, and experience with cGMP documentation.