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

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    "description": "<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold\">About Artiva: </span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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, <a href=\"https://www.artivabio.com/nk-cell-technology/#topic-1\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: bold\">AlloNK®</span></a>, 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.</span></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold\">For more information, visit</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><span style=\"font-weight: bold\"><a href=\"https://www.artivabio.com/\" target=\"_blank\" rel=\"noopener noreferrer\">www.artivabio.com</a></span><span style=\"font-weight: bold\">.</span></span><br></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><span style=\"font-weight: bold\">Job Summary</span>:</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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.</span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"> </span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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.</span></p>\n<p><br><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold\">Responsibilities:</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">BLA and Commercial-Readiness</span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Own end-to-end project management of the process characterization, PPQ, and Commercial readiness workstreams including planning, sequencing, and execution tracking through to completion</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Translate the strategy into actionable execution plans, milestones, and deliverable trackers</span></li>\n</ul>\n</li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Workstream Coordination</span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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 track</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Drive alignment on assumptions, deliverables, and timelines specific to process characterization and PPQ execution</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Provide clear, structured workstream updates and supporting analysis into existing CMC program governance and decision forums</span></li>\n</ul>\n</li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Risk &amp; Issue Management (Workstream Level)</span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Proactively identify risks within the process characterization and PPQ workstreams—including validation, batch execution, documentation, and manufacturing readiness risks</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Develop mitigation options and escalate workstream-level issues with appropriate context and recommended paths forward</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">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</span></li>\n</ul>\n</li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Execution Oversight</span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Track progress against process characterization and PPQ deliverables, including study execution, engineering and PPQ batch manufacturing, release, stability, and validation activities</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Drive PPQ campaign readiness, including coordination of protocols, batch records, documentation, and quality system prerequisites</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Monitor execution against process characterization and PPQ plans across the contributing manufacturing and technical functions, and ensure alignment with workstream expectations</span></li>\n</ul>\n</li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Reporting &amp; Workstream Communication</span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Build and maintain dashboards, trackers, and status reports for the process characterization and PPQ workstreams, providing clear visibility into progress, milestones, and risks</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Report workstream status, key risks, and decision points into existing CMC program governance and leadership forums on a regular cadence</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Translate detailed workstream data into concise, decision-ready summaries for the CMC project lead and senior stakeholders</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Maintain timely, structured communication with functional contributors to keep deliverables and timelines aligned</span></li>\n</ul>\n</li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Process &amp; Continuous Improvement</span>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Develop and refine repeatable tools, trackers, and best practices for managing process characterization and PPQ readiness</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Identify opportunities to improve execution rigor and efficiency within the workstreams</span></li>\n</ul>\n</li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><span style=\"font-weight: bold\">Requirements:</span></span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Bachelor’s degree in life sciences or related field (advanced degree preferred)</span></li>\n</ul>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">6–10+ years of experience in biotechnology or pharmaceutical development</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Demonstrated experience planning, coordinating, or driving process characterization, process validation, and/or PPQ activities</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Strong understanding of GMP manufacturing operations and validation/regulatory expectations</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Proven ability to manage detailed, cross-functional workstreams with multiple internal contributors (and external partners where applicable)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Experience coordinating across internal manufacturing, technical operations, quality, and analytical functions</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Ability to manage competing priorities and other tasks as needed</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold\">Preferred</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Working familiarity with how PPQ campaigns and process validation programs are planned and executed</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Familiarity with regulatory filings (IND/BLA/MAA) and the CMC/validation content they require</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">PMP or similar project management certification (a plus, not required)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Small to mid-size Biotech company experience</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt; font-weight: bold\">Core Competencies</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Execution-focused, with the ability to drive detailed plans to completion</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Effective in a fast-paced, evolving environment</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Strong collaboration and influencing skills; works well as part of a broader CMC project team without requiring direct authority</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Excellent communication skills, including the ability to translate complex technical topics for diverse audiences</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Proactive, solutions-oriented mindset with strong attention to detail</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">In addition to a great culture, we offer:</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">A beautiful facility </span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">An entrepreneurial, highly collaborative, and innovative environment</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Comprehensive benefits, including:</span></li>\n</ul>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Medical, Dental, and Vision</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Group Life Insurance</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Long Term Disability (LTD)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">401(k) Retirement Plan</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Employee Assistance Program (EAP)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Flexible Spending Account (FSA)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Paid Time Off (PTO)</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Company paid holidays, including the year-end holiday week</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">If all this speaks to you, come join us on our journey!</span></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Base Salary: $155,000 - 190,000. Exact compensation may vary based on level, skills and experience.</span></p>\n<p><br></p>",
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