Senior CMC Technical Writer

Immix Biopharma, Inc.; Los Angeles (CA); Híbrido; USD 138.000 - 207.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory writing

Biopharma knowledge

Attention to detail

Ability to work under tight timelines

Communication with SMEs

Educación

Bachelor’s degree in life sciences or engineering

Advanced degree a plus

Herramientas

Veeva Vault

MS Word templates

Document management systems

Descripción del empleo

About Immix Biopharma

Immix Biopharma, Inc. (NASDAQ: IMMX), headquartered in Los Angeles, California, is developing NXC-201, a BCMA-targeted autologous CAR-T cell therapy with a “digital filter,” for relapsed/refractory AL amyloidosis. NXC-201 is being evaluated in NEXICART-2 (NCT06097832), a U.S. multi-center registrational Phase 2 study, and has received FDA Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) designation, as well as Orphan Drug Designation from both FDA and EMA. Immix is targeting a Biologics License Application (BLA) submission in 2027 and is preparing for commercial launch.

Position Summary

The Senior CMC Technical Writer (Contract) will author and edit the chemistry, manufacturing and controls (CMC) content of the first BLA for NXC-201. Reporting to the Associate Director, Regulatory CMC, this contractor will turn manufacturing, analytical and stability source data into clear, accurate Module 3 and Module 2.3 Quality Overall Summary (QOS) sections, together with supporting CMC technical reports, CMC IND amendments and responses to FDA CMC information requests. The role partners with Regulatory CMC, Technical Operations, Quality, Analytical Development and the vector and cell product CDMOs to deliver submission-ready CMC content on the BLA timeline.

Cell therapy and BLA experience are required. Candidates must have written CMC content for cell therapy products and contributed directly to Module 3 of at least one original BLA submitted to FDA.

Key Responsibilities

BLA Module 3 and QOS Authoring

• 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, validation and stability reports, and specifications.
• Prepare CMC IND amendments and draft responses to FDA CMC information requests before and during BLA review.

CMC Technical Source Documents

• Write and edit regulatory-ready CMC technical reports with SMEs: process characterization, PPQ summaries, analytical method validation, stability and comparability.
• Structure reports so their content can be reused directly in Module 3.

Quality and Consistency

• Ensure accuracy, traceability to source data and consistency across Module 3, the QOS and supporting reports.
• Apply company templates and style guide, ICH M4Q structure and eCTD granularity.
• Perform QC and data verification; manage review cycles, comment resolution and version control.

Collaboration and Timelines

• Work with Regulatory CMC, Regulatory Operations (publishing), Technical Operations, Quality, Analytical Development and CDMOs.
• Track deliverables against BLA CMC authoring timelines and flag data gaps or risks early.

Required Qualifications

• Required: CMC technical writing experience for cell therapy products (ideally CAR-T), including viral vector content.
• Required: direct authoring of Module 3 / QOS content for at least one original BLA submitted to FDA (ideally to CBER).
• Bachelor’s degree in life sciences or engineering; advanced degree a plus.
• 7+ years of technical or regulatory writing in biopharma, predominantly CMC content.
• Strong knowledge of ICH M4Q and CTD structure, ICH Q-guidelines relevant to biologics (e.g., Q5A–Q5E, Q6B, Q1, Q2(R2)/Q14) and FDA CGT CMC guidance.
• Proficiency with MS Word templates and document management systems (e.g., Veeva Vault).
• Ability to work independently and deliver high-quality content on short timelines.

Preferred Qualifications

• CAR-T and lentiviral vector CMC content experience.

Key Competencies

• Precision and attention to detail, with disciplined data verification.
• Clear writing that turns complex CMC data into concise regulatory text.
• Organization and responsiveness when working with many SMEs on tight deadlines.

Contract Details and Compensation

Initial 6-month contract with potential for extension based on business needs and performance. Full-time, 40 hours per week; hybrid, based in Los Angeles, CA or remote. Engagement: direct contract with Immix Biopharma (independent contractor; no agency).

Hourly rate: $100–$150 per hour, commensurate with experience. Target start date: December 1, 2026.

Immix Biopharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status or any other characteristic protected by applicable law. Immix Biopharma does not accept unsolicited resumes from agencies.