CMC Technical Writer: Late-Stage Lipids & Process Chemistry (Hybrid)

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

Benefits offered by this job

Medical, dental, vision coverage

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 process chemistry and regulatory documentation. You will translate complex data into clear narratives and ensure traceable, inspection-ready records.

The role emphasizes collaboration with CDMOs and process SMEs, with a hybrid schedule in Boston, MA. A strong background in chemistry and cGMP is essential.

Qualifications

• B.S. or higher in chemistry, engineering, or related field with 4+ years in process chemistry.
• Strong written and verbal English; ability to draft regulatory narratives.
• Familiar with cGMP, 21 CFR Part 211, ICH guidelines for process development.
• Proficiency in MS Word and Excel; experience with EDMS (Veeva Vault, Documentum).
• Experience in process characterization, organic synthesis, and late-stage CMC docs.

Responsibilities

• Draft conclusion-driven process development reports from objectives and SME input.
• Structure reports per internal templates and CMC standards.
• Convert raw data into tables, figures, and summaries without SME pre-story.
• Produce complete first drafts to minimize SME revision.
• Maintain traceable source docs for regulatory submissions and lifecycle docs.
• Collaborate across process development to align reporting and work packages.

Skills

Scientific writing

cGMP documentation

Regulatory documentation

Data analysis

MS Word

MS Excel

EDMS (Veeva Vault)

Cross-functional collaboration

Education

B.S. degree in chemistry, engineering, or related scientific field

M.S. degree in chemistry, engineering, or related scientific field

PhD in chemistry, engineering, or related scientific field

Tools

Veeva Vault

Documentum

Job description

Eurofins USA PSS Insourcing Solutions is seeking a CMC Technical Writer to support Late-Stage Lipids process chemistry and regulatory documentation. You will translate complex data into clear narratives and ensure traceable, inspection-ready records.

The role emphasizes collaboration with CDMOs and process SMEs, with a hybrid schedule in Boston, MA. A strong background in chemistry and cGMP is essential.