Senior Project Manager, CMC
Immunome, Inc.
4 months ago
Remote friendly (Bothell, WA)
United States
Operations
Responsibilities:
- Support and execute the strategic vision for CMC programs; translate strategy into integrated execution plans, key milestones, and decision points.
- Own integrated CMC timelines, governance reporting, and risk/issue management; escalate scope, resourcing, strategic tradeoffs, and budget exceptions to leadership.
- Lead cross-functional execution of the CMC plan to ensure delivery; facilitate alignment, clarify accountability, and escalate tradeoffs/risks as needed.
- Develop, maintain, and drive integrated CMC timelines for manufacturing (critical path, dependencies, scenario planning).
- Coordinate CMC activities to enable efficient, cost-effective production; drive readiness for deliverables (plans, protocols, batch documentation readiness, method readiness) as appropriate by phase.
- Coordinate production of commercial batches as needed with TechOps, Quality, and external manufacturers.
- Optimize meetings and decision-making using agendas, action/owner tracking, decision logs, and follow-through.
- Collaborate with R&D, Quality Assurance, Regulatory Affairs, development, and other departments to integrate CMC activities.
- Liaise with internal stakeholders and external partners (e.g., CDMOs/vendors) on scope, timelines, deliverables, and change control/escalations.
- Keep senior management informed of program timelines, milestones, risks, and decision points; provide escalation paths.
- Lead program/platform dashboards and presentations, including integrated timeline views and RAID summaries.
- Own CMC budget tracking/forecasting; prepare updates and variance analyses; monitor spend vs forecast and coordinate mitigation plans.
Qualifications:
- Bachelor’s degree in a technical field (chemistry, chemical engineering, or pharmaceutical sciences) required; advanced degree preferred.
- Specific project management training desirable.
- Minimum 4 years of Project Management experience in pharmaceutical development/manufacturing with a focus on CMC.
Skills/Experience:
- Proven track record supporting CMC programs from development through commercialization (vendor oversight, integrated plans, governance reporting).
- Strong communication skills; ability to influence and collaborate across diverse teams without direct supervisory authority.
- Ability to manage multiple projects and prioritize effectively in a fast-paced environment.
- Proficiency with project tools/software (e.g., MS Project, SmartSheet, Trello) and MS Office Suite (Word, Excel, PowerPoint).
- Biotech/pharma/healthcare industry experience is a plus.
- Support and execute the strategic vision for CMC programs; translate strategy into integrated execution plans, key milestones, and decision points.
- Own integrated CMC timelines, governance reporting, and risk/issue management; escalate scope, resourcing, strategic tradeoffs, and budget exceptions to leadership.
- Lead cross-functional execution of the CMC plan to ensure delivery; facilitate alignment, clarify accountability, and escalate tradeoffs/risks as needed.
- Develop, maintain, and drive integrated CMC timelines for manufacturing (critical path, dependencies, scenario planning).
- Coordinate CMC activities to enable efficient, cost-effective production; drive readiness for deliverables (plans, protocols, batch documentation readiness, method readiness) as appropriate by phase.
- Coordinate production of commercial batches as needed with TechOps, Quality, and external manufacturers.
- Optimize meetings and decision-making using agendas, action/owner tracking, decision logs, and follow-through.
- Collaborate with R&D, Quality Assurance, Regulatory Affairs, development, and other departments to integrate CMC activities.
- Liaise with internal stakeholders and external partners (e.g., CDMOs/vendors) on scope, timelines, deliverables, and change control/escalations.
- Keep senior management informed of program timelines, milestones, risks, and decision points; provide escalation paths.
- Lead program/platform dashboards and presentations, including integrated timeline views and RAID summaries.
- Own CMC budget tracking/forecasting; prepare updates and variance analyses; monitor spend vs forecast and coordinate mitigation plans.
Qualifications:
- Bachelor’s degree in a technical field (chemistry, chemical engineering, or pharmaceutical sciences) required; advanced degree preferred.
- Specific project management training desirable.
- Minimum 4 years of Project Management experience in pharmaceutical development/manufacturing with a focus on CMC.
Skills/Experience:
- Proven track record supporting CMC programs from development through commercialization (vendor oversight, integrated plans, governance reporting).
- Strong communication skills; ability to influence and collaborate across diverse teams without direct supervisory authority.
- Ability to manage multiple projects and prioritize effectively in a fast-paced environment.
- Proficiency with project tools/software (e.g., MS Project, SmartSheet, Trello) and MS Office Suite (Word, Excel, PowerPoint).
- Biotech/pharma/healthcare industry experience is a plus.