Project/Program Management Lead - CMC

Immix Biopharma is a biopharmaceutical company focused on developing innovative therapies. The Project/Program Management Lead is responsible for integrated program management leadership for the development and commercialization of NXC-201, ensuring effective coordination of cross-functional activities and external partnerships.

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

Requirements:

• Bachelor's degree in life sciences, engineering, pharmacy, biotechnology, or related discipline required
• 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
• 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
• Advanced degree in a scientific, engineering, regulatory, or business discipline preferred
• Project Management Professional certification or equivalent program management training preferred
• Experience with autologous CAR T-cell therapy programs