Senior CMC Writer – Cell Therapy & BLA (Contract, Remote)

Immix Biopharma, Inc.; Los Angeles (CA); Hybrid; USD 138,000 - 207,000; Full time

Job summary

Immix Biopharma, Inc. in Los Angeles, CA, seeks a Senior CMC Technical Writer (Contract) to author and edit Module 3 and QOS for the first BLA for NXC-201. You will translate source data into regulatory content and coordinate with SMEs and CDMOs to meet filing timelines.

Requirements include CAR-T/CMC cell therapy experience, direct Module 3 authoring for a submitted FDA BLA, and a life sciences or engineering degree. 6-month contract, hybrid or remote, with $100–$150/hr.

Qualifications

• Bachelor’s degree in life sciences or engineering; advanced degree a plus.
• 7+ years of technical or regulatory writing in biopharma, predominantly CMC content.
• Experience writing CMC content for cell therapy products (CAR-T) preferred.
• Direct authoring of Module 3 / QOS content for at least one original BLA submitted to FDA.

Responsibilities

• Author and edit Module 3 sections: 3.2.S, 3.2.P, 3.2.A and 3.2.R.
• Write Module 2.3 (QOS) that accurately summarizes and cross-references the Module 3 content.
• Draft from source documents, including batch records, development and stability reports.
• Prepare CMC IND amendments and draft responses to FDA CMC information requests.

Skills

Regulatory writing

Biopharma knowledge

Attention to detail

Ability to work under tight timelines

Communication with SMEs

Education

Bachelor’s degree in life sciences or engineering

Advanced degree a plus

Tools

Veeva Vault

MS Word templates

Document management systems

Job description

Immix Biopharma, Inc. in Los Angeles, CA, seeks a Senior CMC Technical Writer (Contract) to author and edit Module 3 and QOS for the first BLA for NXC-201. You will translate source data into regulatory content and coordinate with SMEs and CDMOs to meet filing timelines.

Requirements include CAR-T/CMC cell therapy experience, direct Module 3 authoring for a submitted FDA BLA, and a life sciences or engineering degree. 6-month contract, hybrid or remote, with $100–$150/hr.