CMC Technical Writer: Process Chemistry & Regulatory Docs

Content Creators; Boston, Northern (MA, KY); Hybrid; USD 55,000 - 68,000; Full time

Benefits offered by this job

Medical coverage

Dental and vision options

401(k) with company match

Paid vacation and holidays

Bonus eligibility

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a CMC Technical Writer to support Late-Stage Lipids Technical Transfer and Process Chemistry. The role emphasizes turning experimental data into clear, compliant documentation while coordinating with CDMOs and project teams.

You will draft high-quality reports, ensure traceability for regulatory submissions, and collaborate across functions to standardize documentation practices in a fast-paced, hybrid work environment in Boston.

Qualifications

• B.S. degree in chemistry, engineering, or related scientific field with 4+ years of industry process chemistry and/or synthetic chemistry experience.
• M.S. in chemistry/engineering with 2+ years of industry process chemistry and/or synthetic chemistry experience.
• Ph.D. in chemistry/engineering with 6+ months of industry process chemistry and/or synthetic chemistry experience.

Responsibilities

• Independently draft conclusion-driven process development reports from protocol objectives and SME input.
• Develop and structure reports per internal templates and late-stage CMC standards.
• Transform raw data into tables, figures, and summaries without SME pre-development.
• Produce complete first drafts requiring minimal SME revision.

Skills

Process chemistry experience

Technical writing

Regulatory documentation

English communication

SOP templates

Education

PhD in chemistry/engineering

MS in chemistry/engineering

B.S. in chemistry/engineering

Tools

MS Word

MS Excel

Veeva Vault

Documentum

Job description

Eurofins USA PSS Insourcing Solutions is seeking a CMC Technical Writer to support Late-Stage Lipids Technical Transfer and Process Chemistry. The role emphasizes turning experimental data into clear, compliant documentation while coordinating with CDMOs and project teams.

You will draft high-quality reports, ensure traceability for regulatory submissions, and collaborate across functions to standardize documentation practices in a fast-paced, hybrid work environment in Boston.