Senior Regulatory CMC Lead — Cell Therapy & BLA

Immix Biopharma, Inc.; Los Angeles (CA); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits

Job summary

Immix Biopharma, Inc. in Los Angeles seeks Associate Director, Regulatory CMC to lead global CMC strategy for NXC-201 and author Module 3 for the BLA. The role partners with FDA CBER and EU readiness, coordinating with operations, QA, analytics and CDMOs.

The ideal candidate has extensive regulatory CMC experience in cell therapy and hands-on Module 3 ownership, with mentoring responsibilities and a track record of successful BLA submissions. Competitive package offered.

Qualifications

• Required: regulatory CMC experience with cell therapy products (autologous/allogeneic, e.g., CAR-T) including lentiviral/retroviral vectors.
• Required: hands-on authorship/ownership of Module 3 for at least one original BLA through FDA review (CBER preferred).
• Bachelor’s degree in life sciences or engineering; advanced degree preferred.
• 10+ years biopharmaceutical experience, including 7+ years regulatory CMC.
• Biologics CMC knowledge per 21 CFR 210/211, 312, 600, 601, 610; ICH Q5A–Q5E, Q6B, Q8–Q12, Q1, Q2(R2)/Q14.
• Experience leading the CMC portion of FDA meetings.
• Excellent technical writing; ability to present complex data clearly.
• Preferred: EU ATMP and MAA experience.

Responsibilities

• Contribute to the global CMC regulatory strategy through licensure and commercial launch.
• Author and review Module 2.3 (QOS) and Module 3: 3.2.S, 3.2.P, 3.2.A and 3.2.R.
• Ensure data packages support licensure: PPQ, method validation, potency, stability/shelf life, comparability.
• Apply FDA CGT CMC flexibilities (PPQ strategy, concurrent release, specifications) where appropriate.
• Support pre-license inspection readiness and responses to CMC information requests during BLA review.
• Author CMC briefing documents, meeting questions and responses to FDA feedback.
• Prepare CMC IND amendments and set phase-appropriate GMP and specification strategies.
• Define vector and starting material strategy (plasmids, cell banks, vector lots across clinical phases).
• Mentor and manage CMC regulatory staff or contractors; build templates and processes.

Skills

Regulatory CMC experience

Cell therapy regulatory

Module 3 authoring

Regulatory leadership

Technical writing

Education

Bachelor’s degree in life sciences or engineering

Advanced degree preferred

Job description

Immix Biopharma, Inc. in Los Angeles seeks Associate Director, Regulatory CMC to lead global CMC strategy for NXC-201 and author Module 3 for the BLA. The role partners with FDA CBER and EU readiness, coordinating with operations, QA, analytics and CDMOs.

The ideal candidate has extensive regulatory CMC experience in cell therapy and hands-on Module 3 ownership, with mentoring responsibilities and a track record of successful BLA submissions. Competitive package offered.