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

Duties/Responsibilities

• Own end-to-end project management of the process characterization, PPQ, and Commercial readiness workstreams 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 workstreams—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 project governance and decision forums
• Risk & Issue Management (Workstream Level): Proactively identify risks within the process characterization and PPQ workstreams—including validation, batch execution, documentation, and CDMO readiness risks
• Develop mitigation options and escalate 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 workstreams, 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 workstream data into concise, decision-ready summaries for the CMC project lead and senior stakeholders
• Maintain timely, structured communication with functional contributors and external partners to keep deliverables and timelines aligned
• Process & Continuous Improvement: Develop and refine repeatable tools, trackers, and best practices for managing process characterization and PPQ readiness
• Identify opportunities to improve execution rigor and efficiency within the workstreams

Requirements

• Bachelor’s degree in life sciences or related field (advanced degree preferred)
• 6–10+ years of experience in biotechnology or pharmaceutical development
• Demonstrated experience supporting or leading process characterization, process validation, and/or PPQ activities
• Strong understanding of GMP manufacturing, CDMO operations, and validation/regulatory expectations
• Proven ability to manage detailed, cross-functional workstreams with multiple contributors and external partners
• Experience working with external partners (e.g., CDMOs)
• Ability to manage competing priorities and other tasks as needed
• Preferred: Direct hands-on experience executing PPQ campaigns or process validation programs
• Familiarity with regulatory filings (IND/BLA/MAA) and the CMC/validation content they require
• PMP or similar project management certification (a plus, not required)