CMC Technical Writer: Hybrid Lipids Process Chemistry

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

Benefits offered by this job

Medical coverage

Dental and vision

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions seeks a CMC Technical Writer to support Late-Stage Lipids Technical Transfer and Process Chemistry. You will translate small molecule synthesis data into clear, scientifically rigorous reports and maintain documentation for regulatory readiness.

The role requires a strong science background, cGMP experience, and the ability to produce first drafts with minimal SME input. Excellent communication and teamwork are essential.

Qualifications

• B.S./M.S./PhD with 2+ years (MS) to 6+ months (PhD) of industry process chemistry or related experience.
• Strong written and verbal English communication.
• Knowledge of cGMP documentation standards and ICH guidelines relevant to process development.

Responsibilities

• Draft conclusion-driven process development reports from protocols and SME input.
• Structure reports per internal templates and late-stage CMC documentation standards.
• Transform raw data into tables, figures and summaries for reports.
• Produce complete first drafts requiring minimal SME revision.
• Maintain traceable, inspection-ready source documentation for submissions.
• Collaborate across process development teams to align reporting and workflows.

Skills

English fluency

cGMP knowledge

Attention to detail

Written communication

Independent work

Project coordination

Education

B.S. in chemistry, engineering or related field

M.S. in chemistry, engineering or related field

PhD in chemistry, engineering or related field

Tools

MS Word

Excel

Veeva Vault or Documentum EDMS

Job description

Eurofins USA PSS Insourcing Solutions seeks a CMC Technical Writer to support Late-Stage Lipids Technical Transfer and Process Chemistry. You will translate small molecule synthesis data into clear, scientifically rigorous reports and maintain documentation for regulatory readiness.

The role requires a strong science background, cGMP experience, and the ability to produce first drafts with minimal SME input. Excellent communication and teamwork are essential.