🌟 We're Hiring: CMC Technical Writer! 🌟
Are you an experienced technical writer with a strong foundation in CMC regulatory submissions and biologics development? We’re looking for a CMC Technical Writer to support global regulatory filings by authoring high-quality technical content for Module 3 and responses to agency questions.
📍 Location: Santa Monica, United States
⏰ Work Mode: Work From Office
💼 Role: CMC Technical Writer
What You'll Do:
📄 Author and finalize Module 3 documents in collaboration with Regulatory CMC and subject matter experts
✍️ Draft and review responses to regulatory agency questions related to CMC content
🧪 Leverage expertise in analytical method development for vector and T-cell products
🧬 Contribute technical insights into extended characterization, comparability, and product specifications
🌍 Ensure alignment with ICH guidelines and global regulatory standards for advanced therapy medicinal products (ATMPs)
What We're Looking For:
✅ Bachelor’s (7+ yrs), Master’s (5+ yrs), or PhD (3+ yrs) in Biochemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry, or related field
✅ Proven experience with CMC regulatory submissions (Module 3)
✅ Excellent technical writing skills and attention to detail
✅ Strong understanding of biologics manufacturing, aseptic processing, and analytical development
✅ Experience with analytical and process development for biotechnology products; cell therapy experience is highly preferred
✅ Ability to communicate complex scientific information clearly and concisely for regulatory audiences
Ready to make an impact? 🚀 Apply now and let's grow together!
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