CMC Technical Writer for Late-Stage Lipid Processes

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

Benefits offered by this job

Medical benefits

Dental & Vision insurance

401(k) with company match

Paid vacation & holidays

Bonus potential

Job summary

Eurofins is seeking a CMC Technical Writer to support Late-Stage Lipids Technical Transfer and Process Chemistry for gene editing products. The role focuses on translating complex data into clear, compliant documentation, enabling regulatory readiness and accelerated development timelines.

You will draft robust reports, maintain inspection-ready records, and collaborate with SMEs and CDMOs, ensuring timely, traceable documentation across programs.

Qualifications

• B.S. degree with 4+ years of industry process chemistry experience; M.S. with 2+ years; PhD with 6 months+ experience.
• Professional fluency in English (written and verbal).
• Working knowledge of cGMP, 21 CFR Part 211, and ICH Q guidelines relevant to process development/manufacturing.
• Proficiency in MS Word and Excel; experience with EDMS platforms (Veeva Vault, Documentum, or similar).
• Experience in process characterization, purification chromatography, and scale-up design.
• Strong compliance mindset for late-stage characterization work.

Responsibilities

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

Skills

Communication skills

Detail oriented

Initiative

Organization

Team collaboration

Education

B.S. in chemistry/engineering

M.S. in chemistry/engineering

PhD in chemistry/engineering

Tools

Veeva Vault

Documentum

MS Word

MS Excel

Job description

Eurofins is seeking a CMC Technical Writer to support Late-Stage Lipids Technical Transfer and Process Chemistry for gene editing products. The role focuses on translating complex data into clear, compliant documentation, enabling regulatory readiness and accelerated development timelines.

You will draft robust reports, maintain inspection-ready records, and collaborate with SMEs and CDMOs, ensuring timely, traceable documentation across programs.