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CMC Project Manager
2 months ago
Title: CMC Project Manager
Location: Seattle WA
Duration: 12 months+
Top Skills:
- 5+ years’ experience in biotech/life sciences project management; cell Therapy experience preferred.
- Bachelor’s degree in STEM/Life Sciences-related discipline.
- Project management qualification preferred
- Proficiency with related software tools such as: MS Project, Office Timeline Pro, Smartsheet, MS PPT, MS Excel, SharePoint, etc.
- Strong knowledge of the biopharma industry. Familiarity/experience with end-to-end CMC drug development.
- Familiarity with alliance management
Job Description:
The Technical Project Manager (PM) will be a key member of the Cell Therapy Development (CTD) Development Operations & Services (DO&S) Portfolio Management Office. This individual will be responsible for overseeing the planning, execution, and delivery of project(s) in alignment with the company's strategy, commitments, and goals. The project(s) will be technical in nature and will support an individual product program or the development portfolio as a whole, with a particular focus on Drug Product Process Development support and alliance management.
The Technical PM will work with stakeholders to identify project scope and strategy, develop detailed project plans, and collaborate with functional leads and project managers to coordinate project deliverables. The Technical PM will manage project timelines, risks, budgets, and resources, communicate project status, and be accountable for project outcomes. They will use CTD DO&S PMO best practices, tools, and templates, and work with internal and external partners to implement effective project management plans. The ideal candidate will be a demonstrated leader with cross-functional experience, able to work under tight deadlines with world-class partners, suppliers, and business leaders.
Primary Responsibilities:
Partner with project, functional, and work stream leads to successfully achieve project objectives inclusive of program assets as well as strategic initiatives.
Apply project management expertise across the portfolio for standard and complex projects, managing one project in detail.
Provide strong team leadership and drive to ensure projects are executed on-time and within budget.
Facilitate the definition of project scope, goals, and deliverables.
Create project plans; scope, work, resources, scheduling, etc.
Maintain project objectives throughout the project lifecycle.
Monitor execution and quality of alliance partner to customer/stakeholder/sponsor standards.
Identify and resolve issues and risks.
Report on project progress, offering viable solutions and opportunities as they arise.
Implement appropriate project change control.
Facilitate all project team meetings; attend related project meetings as necessary to ensure alignment.
Evaluate and assess the results of the project through regular after-action reviews.
Provide structure and leadership across departments to ensure the team meets project objectives.
Work with internal and external stakeholders to manage project deliverables, e.g., CMO’s, Supply Chain, etc.
Develop and communicate status to organizational leadership.
CMC Support and Sub-Team Management Responsibilities:
- Lead and coordinate Drug Product Process Development and related CMC sub-teams to ensure alignment with overall project goals and timelines.
- Collaborate closely with CMC functional areas, including process development, analytical development, quality, and regulatory, to support project objectives.
- Develop and maintain detailed CMC project plans, including resource allocation, risk management, and timeline tracking.
- Facilitate cross-functional CMC sub-team meetings to ensure alignment and address any CMC-related issues or risks.
- Monitor and report on the progress of Drug Product Process Development activities, ensuring that all milestones are met and any deviations are promptly addressed.
- Ensure clear communication and collaboration across all involved teams.
- Ensure compliance with regulatory requirements and industry standards in all CMC activities.
- The ideal candidate will have a strong background in project management and CMC support, with the ability to lead cross-functional teams and manage complex projects in a dynamic environment.
Competencies & Experiences:
- 5+ years’ experience in bio tech/life sciences project management; cell Therapy experience preferred.
- Bachelor’s degree in STEM/Life Sciences-related discipline.
- Project management qualification preferred
- Proficiency with related software tools such as: MS Project, Office Timeline Pro, Smartsheet, MS PPT, MS Excel, SharePoint, etc.
- Strong knowledge of biopharma industry. Familiarity/experience with end-to-end CMC drug development.
- Familiarity with alliance management
- Excellent interpersonal, communication, and presentation skills.
- Ability to work cross-functionally, with matrixed teams; maintaining strong business partner relationships.
- Strong leadership skills and executive presence; ability to positively influence outcomes.
- Expertise in conflict resolution.
- Excellent critical thinking and problem-solving skills.
- Willingness to do what needs to be done in a dynamic environment.
