Project Manager - Drug Substance CMC Operations

Job Title: Project Manager - Drug Substance CMC OperationsLocation: Seattle, Washington (On-site/Hybrid)Employment Type: W2 ContractDuration: 12 monthsHybrid to Seattle, WA - 2-3 days week/ onsiteAbout the Role:We are seeking a detail-driven and motivated Associate Director/Project Manager to join our Commercial Manufacturing and Supply Chain (CMSC) team under the POVE program. This pivotal role will focus on supporting cross-functional project teams in executing CMC manufacturing strategies, collaborating closely with CDMOs, and driving key milestones across manufacturing, validation, and testing.As part of this dynamic environment, you will work alongside internal and external stakeholders to track project scope, timelines, milestones, and capacity planning. The role offers visibility and the opportunity to contribute to high-impact projects in the biotech industry.Key Responsibilities:Collaborate with program leads, functional area leads, and CDMOs to develop, maintain, and monitor manufacturing, validation, and testing project plans.Track key milestones and critical path activities, ensuring alignment with project objectives.Communicate effectively with internal teams and external partners on status updates, risks, and mitigation plans.Manage team communications, including agendas, meeting minutes, decision logs, task lists, and risk mitigation strategies.Maintain project tools such as action logs, risk registers, budgets, and reporting dashboards.Create and implement templates for streamlined team activities.Ensure compliance with established SOPs and GxP requirements.Qualifications:Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree (MS, PhD, MBA) or PMP certification is preferred.At least 8 years of experience in the biopharmaceutical industry, with 5+ years in project management for biopharmaceutical products.Proven expertise in biologics manufacturing and managing external CDMOs.Solid understanding of GMPs, the drug development lifecycle, and regulatory submissions.Strong analytical and problem-solving skills, with the ability to prioritize and manage competing tasks in a cross-functional, matrixed environment.Proficiency in Microsoft Office Suite (Project, PowerPoint, Excel, SharePoint); familiarity with additional PM tools like Smartsheet or Primavera is a plus.Excellent communication and facilitation skills for diverse stakeholders across organizational levels.

Created: 2025-01-24