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

Cmc Project Management ProfessionalWe 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.Job Summary:We are seeking an experienced CMC Project Management professional to lead the planning and execution of our process characterization and Process Performance Qualification (PPQ) workstreams. This role owns the detailed timelines, deliverables, and day-to-day coordination required to advance these specific workstreams from strategy through execution, ensuring validation and manufacturing readiness milestones are met.This is a hands-on project-management role.

The successful candidate will drive the operational rhythm within the process characterization and PPQ workstreams—managing schedules, tracking deliverables, surfacing risks early, and keeping the contributing functions aligned on what is due and when. The emphasis is on planning, coordinating, and driving these activities to completion rather than personally performing the characterization or validation studies. 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.Responsibilities:BLA and Commercial-Readiness Own end-to-end project management of the process characterization, PPQ, and Commercial readiness workstreams including planning, sequencing, and execution tracking through to completionDevelop 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 scheduleTranslate the strategy into actionable execution plans, milestones, and deliverable trackersWorkstream Coordination Coordinate the functional contributors to these workstreams—including internal Technical Operations, Manufacturing, Analytical Development, and Quality (and external partners where applicable)—to keep deliverables on trackCoordinate with adjacent PPQ readiness activities—including supplier and raw material qualification and equipment/facility qualification—tracking them as dependencies and ensuring alignment with campaign timelinesDrive alignment on assumptions, deliverables, and timelines specific to process characterization and PPQ executionProvide clear, structured workstream updates and supporting analysis into existing CMC program governance and decision forumsRisk & Issue Management (Workstream Level) Proactively identify risks within the process characterization and PPQ workstreams—including validation, batch execution, documentation, and manufacturing readiness risksDevelop mitigation options and escalate workstream-level issues with appropriate context and recommended paths forwardTrack dependencies that could affect PPQ timing or downstream regulatory and clinical supply needs, and flag them to the CMC project lead for cross-program visibilityExecution Oversight Track progress against process characterization and PPQ deliverables, including study execution, engineering and PPQ batch manufacturing, release, stability, and validation activitiesDrive PPQ campaign readiness, including coordination of protocols, batch records, documentation, and quality system prerequisitesMonitor execution against process characterization and PPQ plans across the contributing manufacturing and technical functions, and ensure alignment with workstream expectationsReporting & Workstream Communication Build and maintain dashboards, trackers, and status reports for the process characterization and PPQ workstreams, providing clear visibility into progress, milestones, and risksReport workstream status, key risks, and decision points into existing CMC program governance and leadership forums on a regular cadenceTranslate detailed workstream data into concise, decision-ready summaries for the CMC project lead and senior stakeholdersMaintain timely, structured communication with functional contributors to keep deliverables and timelines alignedProcess & Continuous Improvement Develop and refine repeatable tools, trackers, and best practices for managing process characterization and PPQ readinessIdentify opportunities to improve execution rigor and efficiency within the workstreamsRequirements:Bachelor's degree in life sciences or related field (advanced degree preferred)6–10+ years of experience in biotechnology or pharmaceutical developmentDemonstrated experience planning, coordinating, or driving process characterization, process validation, and/or PPQ activitiesStrong understanding of GMP manufacturing operations and validation/regulatory expectationsProven ability to manage detailed, cross-functional workstreams with multiple internal contributors (and external partners where applicable)Experience coordinating across internal manufacturing, technical operations, quality, and analytical functionsAbility to manage competing priorities and other tasks as neededPreferredWorking familiarity with how PPQ campaigns and process validation programs are planned and executedFamiliarity with regulatory filings (IND/BLA/MAA) and the CMC/validation content they requirePMP or similar project management certification (a plus, not required)Small to mid-size Biotech company experienceCore Competencies:Execution-focused, with the ability to drive detailed plans to completionEffective in a fast-paced, evolving environmentStrong collaboration and influencing skills; works well as part of a broader CMC project team without requiring direct authorityExcellent communication skills, including the ability to translate complex technical topics for diverse audiencesProactive, solutions-oriented mindset with strong attention to detailIn addition to a great culture, we offer:A beautiful facilityAn entrepreneurial, highly collaborative, and innovative environmentComprehensive benefits, including:Medical, Dental, and VisionGroup Life InsuranceLong Term Disability (LTD)401(k) Retirement PlanEmployee Assistance Program (EAP)Flexible Spending Account (FSA)Paid Time Off (PTO)Company paid holidays, including the year-end holiday weekOur recognition program, Bonus.ly, is where you can trade in points earned for things you want.If all this speaks to you, come join us on our journey!Base Salary: $155,000 - 190,000.

Exact compensation may vary based on level, skills and experience.