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, is preparing for commercial launch, and plans a randomized frontline Phase 3 trial in 2027.

Position Summary

The Associate Director, Regulatory CMC will be the regulatory CMC lead for NXC-201 as Immix prepares its first BLA. Reporting to the SVP, Head of Regulatory Affairs, this leader will develop and execute the global CMC regulatory strategy and author and own Module 3 of the original BLA. The role leads CMC interactions with FDA CBER’s Office of Therapeutic Products, supports EU readiness, and partners with Technical Operations, Quality, Analytical Development and the vector and cell product CDMOs.

Cell therapy and BLA experience are required. Candidates must bring regulatory CMC experience with cell therapy products (e.g., CAR-T or other genetically modified cell therapies) and hands-on authorship/ownership of Module 3 for at least one original BLA submitted to FDA.

Key Responsibilities

CMC Strategy and BLA

·      Contribute to the global CMC regulatory strategy for NXC-201 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 lead responses to CMC information requests during BLA review.

·      If needed, contribute to the CMC components of Agency meetings interactions.

·      Author CMC briefing documents, meeting questions and responses to FDA feedback.

IND Lifecycle and Change Control

·      Prepare CMC IND amendments and set phase-appropriate GMP and specification strategies.

·      Assess manufacturing changes and comparability, consistent with FDA’s draft guidance on CGT comparability.

·      Define vector and starting material strategy (plasmids, cell banks, vector lots across clinical phases).

·      Manage master files and Letters of Authorization with CDMOs and suppliers.

Compliance and Release Testing

·      Advise on release specifications: rapid/alternative sterility (USP <71>/<72>), RCL testing, potency assays.

·      Assess the regulatory impact of deviations and OOS results; review CoA and labeling CMC content.

Global, Post-Approval and Leadership

·      Author EU IMPD/CTIS CMC sections and plan MAA Module 3 (EU GMP Part IV for ATMPs, QP considerations).

·      Define post-approval change strategy: 21 CFR 601.12 supplements, annual reports and PMCs.

·      Mentor and manage CMC regulatory staff or contractors; build templates and processes.

Required Qualifications

·      Required: regulatory CMC experience with cell therapy products (autologous or allogeneic, ideally CAR-T), including lentiviral/retroviral vector considerations.

·      Required: hands-on authorship/ownership of Module 3 for at least one original BLA through FDA review (ideally CBER, ideally a cell therapy BLA).

·      Bachelor’s degree in life sciences or engineering; advanced degree preferred.

·      10+ years of biopharmaceutical experience, including 7+ years in regulatory CMC (or equivalent with a PhD).

·      Biologics CMC knowledge: 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, with the ability to turn complex data into clear regulatory positions.

Preferred Qualifications

·      Viral vector CMC depth (lentiviral or retroviral vector manufacturing, testing and comparability).

·      PPQ, pre-license inspection and CDMO management experience.

·      EU ATMP and MAA experience.

Key Competencies

·      Scientific rigor and sound, risk-based regulatory judgment.

·      Clear, persuasive communication with technical teams, CDMOs and health authorities.

What We Offer

Competitive base salary [Insert salary range – required for California postings], annual bonus, equity, and comprehensive benefits [Add benefits details].

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.