Tap Growth ai
CMC Technical Writer/ Regulatory Technical Writer
Tap Growth ai, Santa Monica, California, United States, 90403
CMC Technical Writer/ Regulatory Technical Writer
We are hiring a CMC Technical Writer to support global regulatory filings by authoring high-quality technical content for Module 3 and responses to agency questions. This role focuses on CMC regulatory submissions and biologics development, with an emphasis on advancing documentation that aligns with regulatory standards for ATMPs.
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+ years), Master’s (5+ years), or PhD (3+ years) 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!
#J-18808-Ljbffr
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+ years), Master’s (5+ years), or PhD (3+ years) 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!
#J-18808-Ljbffr