Immix Biopharma, Inc. Project/Program Management Lead - CMC Remote · Full time Company website

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Position Summary

The Project/Program Lead is responsible for providing integrated program management leadership for the development, regulatory advancement, manufacturing readiness, and potential commercialization of NXC-201, an autologous cell therapy product.

This individual will partner with internal cross-functional teams and external manufacturing and testing organizations to develop and execute the integrated program plan. The Project/Program Lead will ensure that cross-functional activities, dependencies, risks, decisions, and deliverables are effectively coordinated to support clinical development, regulatory submissions, process validation, and commercial readiness.

The successful candidate will have experience managing complex cell and gene therapy programs involving multiple external partners, interdependent technical workstreams, and aggressive regulatory timelines. The role requires strong organizational leadership, scientific and technical fluency, proactive risk management, and the ability to drive accountability across internal teams, CDMOs, testing laboratories, consultants, and academic partners.

Key Responsibilities

• Develop, coordinate and manage the integrated NXC-201 program plan, including clinical, CMC, regulatory, quality, manufacturing, analytical, supply chain, and commercial-readiness activities.
• Translate program strategy into clear workstreams, milestones, deliverables, decision points, dependencies, and resource requirements.
• Establish program governance, meeting structures, escalation pathways, decision-making processes, and communication expectations.
• Facilitate cross-functional program team meetings and ensure that decisions, action items, risks, and commitments are documented and tracked to completion.
• Provide clear and timely program updates to executive leadership, including progress against timeline, critical milestones, emerging risks, resource constraints, and decisions requiring leadership input.
• Promote alignment between program objectives, corporate priorities, regulatory commitments, and available resources.
• Coordinate activities supporting the NXC-201 drug product, drug substance, viral vector, starting material, and biological raw material control strategies.
• Integrate timelines for process development, process characterization, technology transfer, engineering runs, analytical method development, method qualification, validation, method transfer, comparability, stability, and process performance qualification.
• Coordinate readiness activities across internal technical functions and external manufacturing partners.
• Track dependencies between process characterization, analytical validation, comparability, PPQ, stability, and regulatory submission activities.

Qualifications

Education

• Bachelor’s degree in life sciences, engineering, pharmacy, biotechnology, or related discipline required.
• Advanced degree in a scientific, engineering, regulatory, or business discipline preferred.
• Project Management Professional certification or equivalent program management training preferred.

Experience

• Minimum of 8 years of experience in biotechnology, pharmaceutical development, cell and gene therapy, or related regulated industry.
• Minimum of 5 years of experience in project management, program management, alliance management, CMC operations, or technical operations.
• Demonstrated experience managing complex, cross-functional product development programs.

Required Knowledge and Competencies

• Strong understanding of the biotechnology product-development lifecycle.
• Working knowledge of manufacturing, analytical testing, quality systems, clinical supply, and regulatory development.
• Ability to understand and integrate complex scientific, technical, regulatory, quality, and operational information.
• Demonstrated ability to manage critical-path activities, interdependent workstreams, and competing priorities.

Preferred Experience

• Experience with autologous CAR T-cell therapy programs.