Tap Growth ai is hiring: CMC Technical Writer in Santa Monica

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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 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!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  IT Services and IT Consulting

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