🌟 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!
...Start a meaningful career as a Housekeeper with Mountain Vista Senior Living. Make a difference in someone's life everyday. At Mountain... ..., or healthcare setting required Long-term care or hospital housekeeping experience preferred Strong communication skills...
...All duties are included in the job but not limited to: Assist with daily golf shop and outside operations. Check-in members... ...Preferred candidate would be a Senior looking for a 7/8 month internship, Dates flexible-March/April-October/November.Ideal candidate...
...and machine interface solutions for industry titans that drive the world economy and lead technical advancements including:NASA, Honeywell, Boeing, Pratt and Whitney, and GE. This is an opportunity to bring together your years of experience and intimate programming knowledge...
...Benefits! Job Description What you will be doing: Oversee the construction and delivery of both new construction and renovation projects ranging from $1 - $15+ million. Manage 3-6 projects concurrently under limited supervision. Handle scheduling...
...Empire National is currently seeking a dedicated and experienced Team Driver with a Class A Commercial Driver License (CDL) to join our fleet in Woodridge, IL. As a Team Driver, you and your partner will work together to safely and efficiently transport goods, ensuring...