$70K - 75K a year
Author and finalize Module 3 CMC documents, draft regulatory responses, and ensure compliance with global regulatory standards for biologics.
Bachelor’s or higher in biochemical/biomedical engineering or related field with 5-7+ years experience in CMC regulatory submissions and strong biotech technical writing skills.
Join to apply for the CMC Technical Writer role at Tap Growth ai2 days ago Be among the first 25 applicantsJoin to apply for the CMC Technical Writer role at Tap Growth aiGet AI-powered advice on this job and more exclusive features. 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 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 WriterWhat You'll Do Author and finalize Module 3 documents in collaboration with Regulatory CMC and subject matter experts️ 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 audiencesReady to make an impact? Apply now and let's grow together!Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionOtherIndustriesIT Services and IT ConsultingReferrals increase your chances of interviewing at Tap Growth ai by 2xGet notified about new Technical Writer jobs in Santa Monica, CA.Calabasas, CA $70,000.00-$75,000.00 4 days agoAssociate Tech Editor and Writer / Tech Editor and Writer (AHT) - R10202000Redondo Beach, CA $55,600.00-$100,700.00 3 weeks agoCulver City, CA $110,000.00-$118,000.00 1 month agoLos Angeles, CA $81,120.00-$117,173.33 2 weeks agoCarson, CA $75,000.00-$110,000.00 5 days agoLos Angeles Metropolitan Area $60,000.00-$75,000.00 2 weeks agoUniversal City, CA $48.00-$55.00 1 day agoCarson, CA $75,000.00-$110,000.00 5 days agoTechnology Learning & Development Technical WriterLos Angeles, CA $90,000.00-$100,000.00 2 weeks agoLawndale, CA $50,000.00-$75,000.00 1 month agoRelease and Deployment Consultant II - Technical WriterLos Angeles, CA $88,000.00-$130,000.00 1 month agoTorrance, CA $128,000.00-$138,000.00 3 days agoHawthorne, CA $80,000.00-$100,000.00 1 week agoBusiness Analyst (GRC - Governance Risk Compliance)Universal City, CA $110,000.00-$110,000.00 1 day agoAI Transformation Business Analyst - Build the Tech Behind the #PixiGlowSanta Monica, CA $64,300.00-$86,200.00 1 month agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
This job posting was last updated on 9/4/2025