CMC Technical Writer: Process Chemistry & Regulatory Docs

Eurofins PSS Insourcing Solutions; Boston (KY); Hybrid; USD 114,616,000 - 140,405,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with company match

Paid vacation and holidays

Bonus potential

Job summary

Eurofins PSS Insourcing Solutions seeks a CMC Technical Writer to support late-stage Lipids technical transfer and process chemistry, translating experimental data into clear, publication-quality documents. You will work with project teams to drive documentation for regulatory readiness and lifecycle knowledge management.

The role emphasizes drafting high-quality reports, aligning with cGMP standards, and collaboration across programs. Hybrid schedule, Boston area, with onsite days.

Qualifications

• BS degree in chemistry, engineering, or related field with 4+ years of industry process chemistry experience; MS with 2+ years; PhD with 6 months+.
• Professional fluency in English.
• Working knowledge of cGMP documentation standards, 21 CFR Part 211, and ICH Q guidelines relevant to process development and manufacturing.
• Proficiency in MS Word, Excel; experience with EDMS platforms (Veeva Vault, Documentum, or similar).
• Experience in process characterization, process chemistry, and process development including purification chromatography and scaling design.
• Strong compliance foundations for late-stage characterization work.
• Attention to detail, data analysis, troubleshooting abilities.
• Ability to meet deliverables with minimal supervision, stay on timeline, and work independently.
• Excellent interpersonal communication and ability to collaborate in a multi-disciplinary team.

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 pre-developing the storyline.
• Produce substantively complete first drafts with minimal SME revisions.
• Maintain traceable, inspection-ready source documentation for regulatory submissions and knowledge management.
• Collaborate across process development to standardize documentation practices and align reporting.

Skills

Strong written and verbal

English fluency

Attention to detail

Independent initiative

Team collaboration

Education

B.S. in chemistry/engineering

M.S. in chemistry/engineering

Ph.D. in chemistry/engineering

Tools

MS Word

Excel

EDMS (Veeva Vault / Documentum)

Job description

Eurofins PSS Insourcing Solutions seeks a CMC Technical Writer to support late-stage Lipids technical transfer and process chemistry, translating experimental data into clear, publication-quality documents. You will work with project teams to drive documentation for regulatory readiness and lifecycle knowledge management.

The role emphasizes drafting high-quality reports, aligning with cGMP standards, and collaboration across programs. Hybrid schedule, Boston area, with onsite days.