CMC Project Manager

Job Title: CMC Project Manager
Location: Seattle, WA
Duration: 12 Months +

Pay Range: $50.44 - $52.44/hr. on w2
Top Skills:

• Experience in the Biotech/Cell Therapy industry Preferred
• PMP Experience Preferred
• Experience with Smartsheets, Tableau, and MS Projects
• Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.

 
Summary:
The Project Manager is closely partnered with the Leader to enable effective execution of strategy and plans. The Product of responsibilities of the Project Manager fall into 4 general categories which flex across all drug modalities, disease areas and stages of development.
1. Cross-functional Project Management to ensure integrated execution of LCM strategy and communication
2. Project Timeline Management and timeline scenario planning
3. Assist with Gaps Analysis and Risks Management
4. Ensure connectivity with key partners on critical actions, timelines etc
 
Primary Responsibilities:

• In partnership with Team Leader, manage multiple commercial LCM program assignments (actual number determined by level of project complexity and candidate experience) and drive execution of integrated program strategy
• Develop detailed project plan that is aligned with the overall strategy. Work collaboratively with the CTO team leaders and cross functional teams to track all project milestones
• Facilitate pertinent scenario planning to address changing business/clinic needs. Gather stakeholder input, evaluate, collate, manage and communicate implications and adjustments to the overall plan
• Manage all meeting logistics including the creation of clear, concise minutes
• Partner with the GM&ST Leader to facilitate the management and communication of program risks and mitigation strategies
• Leverage portfolio and program management tools to track program execution, milestones, risks, and long-range planning to ensure appropriate communication to team members and management. Examples include MS Project Server, ePlan, PSI CMC database, OnePager Pro, DOI Tool, Right First Time Scorecard, Operational Risk Management
• Coordinate and ensure appropriate allocation of DS and API materials for non-clinical use

 
Experience / Qualifications:

• Bachelor's degree in engineering or relevant scientific discipline with at least 5 years of relevant experience / Masters’ degree with a minimum of 2-6 years of relevant experience
• Highly motivated self-starter that works well both in teams as well as independently
• Strong project management, business process management, and optimization skills
• Familiarity with end-to-end CMC drug development with an understanding of critical milestones and typical bottlenecks preferred
• Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.
• Demonstrated ability to accomplish results and meet deadlines and commitments
• Strong interpersonal and communications skills, both oral a written
• Demonstrated proficiency in MS Project, PowerPoint, Excel and Word
• Demonstrated ability to build relationships, influence, negotiate, and drive organizational engagement
• Experience developing and/or managing program management tools to forecast budgets, timelines and resources preferred
• PMP Preferred