CMC Technical Writer - Synthetic Chemistry

📋 Description

• Independently draft conclusion-driven process development reports from protocol objectives and
• Develop and structure reports in alignment with internal templates and late-stage CMC documentation
• Transform raw experimental data (in-process controls, yield/purity results, scale comparisons, and
• Produce substantively complete first drafts that require minimal SME revision, reducing review
• Maintain traceable and inspection-ready source documentation to support regulatory submissions
• Collaborate across broader process development functions to establish best Documentation practices

🎯 Requirements

• B.S. degree in chemistry, engineering, or related scientific field with 4+ years of industry
• Strong written and verbal communication skills, with professional fluency in English.
• Working knowledge of cGMP documentation standards, 21 CFR Part 211, and ICH Q guidelines relevant
• Proficiency in MS Word, Excel; experience with at least one EDMS platform (Veeva Vault, Documentum
• Experience in process characterization, process chemistry, and process development including
• Strong foundation in compliance expectations for late-stage characterization work.

🎁 Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for yearly goal-based bonus & merit-based increases