Technical Project Manager
Omni Inclusive
Position: Technical Project Manager
Location: Seattle WA
Top Skills:
• 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
• 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.
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