Hybrid CMC Technical Writer - Process Chemistry

Eurofins US Network; Boston (MA); Hybrid; USD 55,000 - 68,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Yearly bonus potential

Merit-based pay increases

Job summary

Eurofins USA PSS Insourcing Solutions in Boston, MA seeks a CMC Technical Writer to support late‑stage Lipids process characterization and regulatory readiness. You will translate experimental data into concise reports and craft scientifically rigorous narratives aligned with cGMP standards.

The role requires documenting with minimal SME input, using internal templates, and producing audit‑ready documentation. Hybrid schedule with three onsite days per week.

Qualifications

• BS in chemistry/engineering or related field with 4+ years of industry process chemistry experience.
• MS in chemistry/engineering or related field with 2+ years of industry process chemistry experience.
• PhD in chemistry/engineering or related field with 6 months+ of industry process chemistry experience.
• Proficiency with cGMP documentation standards, 21 CFR Part 211, and ICH Q guidelines.
• English language proficiency; strong written and verbal communication.

Responsibilities

• Independently draft conclusion‑driven process development reports from objectives and SME input.
• Conform reports to internal templates and late‑stage CMC standards with proper rationale and data presentation.
• Convert raw data into tables/figures and draft narratives without extensive SME prep.
• Produce complete first drafts minimizing SME revisions and review cycles.
• Maintain traceable, inspection‑ready source documentation for regulatory submissions.
• Collaborate across process development to align reporting approaches and packages.

Skills

Strong written/verbal communication

English fluency

Attention to detail

Independent / self-motivated

Project management / multitasking

Team collaboration

Education

BS in chemistry/engineering or related field

MS in chemistry/engineering or related field

PhD in chemistry/engineering or related field

Tools

MS Word

MS Excel

EDMS (Veeva Vault / Documentum)

Job description

Eurofins USA PSS Insourcing Solutions in Boston, MA seeks a CMC Technical Writer to support late‑stage Lipids process characterization and regulatory readiness. You will translate experimental data into concise reports and craft scientifically rigorous narratives aligned with cGMP standards.

The role requires documenting with minimal SME input, using internal templates, and producing audit‑ready documentation. Hybrid schedule with three onsite days per week.