CMC Technical Writer - Tech Transfer & Process Chemistry

📋 Description

• Draft conclusion-driven process development reports from objectives and SME input, translating
• Structure reports per internal templates and late-stage CMC documentation standards with rationale
• Transform raw experimental data into tables, figures, and summaries for regulatory readiness and
• Produce complete first drafts with minimal SME revision to accelerate documentation timelines.
• Maintain traceable, inspection-ready source documentation to support submissions and lifecycle
• Collaborate across process development functions to align reporting approaches across programs.

🎯 Requirements

• B.S. or higher in chemistry, engineering, or related field; 4+ years (or M.S. with 2+ years; PhD
• Strong written and verbal English; familiarity with cGMP, 21 CFR Part 211, and ICH guidelines
• Proficiency in MS Word, Excel; experience with an EDMS (Veeva Vault, Documentum, or similar).
• Experience in process characterization, purification chromatography, scaling design, and late-stage
• Attention to detail, data analysis, and problem-solving; ability to work independently and meet
• Ability to work in the United States indefinitely without sponsorship.

🎁 Benefits

• Comprehensive medical, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Bonus opportunities and merit-based increases