Senior Manager​/Associate Director, CMC Project Management - Process Development & Validation

About Artiva

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs).

We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

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We are seeking an experienced CMC Project Management professional to lead the planning and execution of our process characterization and Process Performance Qualification (PPQ) work streams. This role owns the detailed timelines, deliverables, and day-to-day coordination required to advance these specific work streams from strategy through execution, ensuring validation and manufacturing readiness milestones are met.

This is a hands‑on, execution‑focused role. The successful candidate will drive the operational rhythm within the process characterization and PPQ work streams—managing schedules, tracking deliverables, surfacing risks early, and keeping contributing functions and external partners aligned on what is due and when. Workstream status and key decisions feed into the broader CMC project management framework, partnering closely with the CMC project lead and other workstream owners to maintain overall program alignment.

• BLA and Commercial Readiness
• Own end‑to‑end project management of the process characterization, PPQ, and Commercial readiness work streams including planning, sequencing, and execution tracking through to completion
• Develop and maintain detailed, bottoms‑up workstream timelines and resource planning for process characterization, validation activities, and PPQ campaigns, and ensure they integrate cleanly into the overall CMC program schedule
• Translate the strategy into actionable execution plans, milestones, and deliverable trackers
• Workstream Coordination
• Coordinate the functional contributors to these work streams—including Technical Operations, internal, and external partners (CDMOs, CROs)—to keep deliverables on track
• Coordinate with adjacent PPQ readiness activities—including supplier and raw material qualification and equipment/facility qualification—tracking them as dependencies and ensuring alignment with campaign timelines
• Drive alignment on assumptions, deliverables, and timelines specific to process characterization and PPQ execution
• Provide clear, structured workstream updates and supporting analysis into existing CMC program governance and decision forums
• Risk & Issue Management (Workstream Level)
• Proactively identify risks within the process characterization and PPQ work streams—including validation, batch execution, documentation, and CDMO readiness risks
• Develop mitigation options and elevate workstream‑level issues with appropriate context and recommended paths forward
• Track dependencies that could affect PPQ timing or downstream regulatory and clinical supply needs, and flag them to the CMC project lead for cross‑program visibility
• Execution Oversight
• Track progress against process characterization and PPQ deliverables, including study execution, engineering and PPQ batch manufacturing, release, stability, and validation activities
• Drive PPQ campaign readiness, including coordination of protocols, batch records, documentation, and quality system prerequisites
• Monitor CDMO execution against process characterization and PPQ plans and ensure alignment with workstream expectations
• Reporting & Workstream Communication
• Build and maintain dashboards, trackers, and status reports for the process characterization and PPQ work streams, providing clear visibility into progress, milestones, and risks
• Report workstream status, key risks, and decision points into existing CMC program governance and leadership forums on a regular cadence
• Translate detailed…