Hybrid CMC Technical Writer, Synthetic Chemistry

Eurofins; Boston (MA); Hybrid; USD 83,000 - 102,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS is hiring a CMC Technical Writer to join the Synthetic Chemistry team in a hybrid role based near Boston, MA. The role focuses on translating complex process development data into clear, inspection-ready documentation that supports regulatory submissions and lifecycle management.

The ideal candidate brings a strong chemistry background, 4+ years of industry experience, and proficiency with cGMP documentation standards.

Qualifications

• BS in chemistry/engineering with 4+ years of industry process chemistry or synthetic chemistry experience; MS with 2+ years; PhD with 6 months+ experience.
• Strong written and verbal English communication.
• Working knowledge of cGMP, 21 CFR Part 211, and ICH guidelines relevant to process development and manufacturing.
• Proficiency in MS Word and Excel; experience with at least one EDMS platform.
• Experience in process characterization, process chemistry, and organic synthesis.

Responsibilities

• Draft conclusion-driven process development reports from objectives and SME input.
• Structure reports per internal templates and late-stage CMC standards.
• Transform raw data into tables, figures, and summaries.
• Produce first drafts with minimal SME revision.
• Maintain traceable, inspection-ready documentation for regulatory submissions.
• Collaborate across process development to align reporting and work packages.

Skills

Communication skills

Attention to detail

Organization

Self-motivation

Time management

Education

Bachelor's or higher in chemistry

MS in chemistry or related field

PhD in chemistry or related field

Tools

MS Word

MS Excel

EDMS (Veeva Vault or Documentum)

Job description

Eurofins USA PSS is hiring a CMC Technical Writer to join the Synthetic Chemistry team in a hybrid role based near Boston, MA. The role focuses on translating complex process development data into clear, inspection-ready documentation that supports regulatory submissions and lifecycle management.

The ideal candidate brings a strong chemistry background, 4+ years of industry experience, and proficiency with cGMP documentation standards.