Senior Project Manager

Senior Project Manager (Direct Hire)

Brisbane, CA

Job Requisition: 6396

Description for Sr. Project Manager:
The Project Manager will manage one of our growing CRISPR-based molecular diagnostic programs as we bring them from concept to market.  The project manager will be responsible for managing the scope for the DARPA projects, estimating resources and schedules, understanding and mitigating risks and executing the project to the plan. Working in collaboration with the internal technical teams, external service providers and our development partners, the project manager is responsible for the development and implementation of new processes and procedures, as well as project oversight to support government compliance.

Responsibilities for Sr. Project Manager: 
  • Responsible for project management of the DARPA programs for a cutting-edge diagnostic device utilizing CRISPR technology working with internal and external stakeholders
  • Define, plan, and direct the execution of a broad range of complex technical programs/projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk
  • Responsible for proactive communication in collaboration with functional directors and managers to assure integration of project, company, and functional goals towards achieving project milestones and timetables
  • Ensure project objectives/requirements are clear and agreed to by all stakeholders
  • Provide critical thinking and leadership when issues arise during execution of project activities
  • Document and manage project risks, issues and action items and document actions necessary to mitigate risks
  • Prepare presentations/reports with support from technical leads for the prime contractor and/or DARPA
  • Coordinate with finance team to ensure timely submission of deliverables for milestone-based payments
  • Oversight of all phases of the product development process from Concept to Launch
  • Generate the necessary documentation including project plans, SOWs, protocols, reports, etc.
Requirements for Sr. Project Manager:
  • Bachelor's degree in engineering, life sciences or related technical field
  • Minimum 5 years project management experience in a regulated biotech, medical device, and/or In Vitro Diagnostics environment
  • Solid knowledge of FDA regulations, Premarket Approval (PMA), 510(k) process, 21 CFR Part 820 and ISO 13485
  • Strong background in project and program management with related processes and techniques, including Agile/Scrum and Waterfall approaches
  • Experience with project management tools (SmartSheet, MS Project, Primavera)
  • Experience using resource planning/management tools
  • Highly analytical with attention to detail
  • Demonstrated leadership experience, including the ability to successfully influence others to achieve objectives in an environment of competing priorities
  • Strong teamwork, work ethic and organizational skills
  • Excellent written and verbal communication skills
  • Ability to function effectively in a fast-paced work environment
Desired Skills for Sr. Project Manager:
  • Project Management Professional (PMP) Certification
*Legal authorization to work in the U.S. is required. Will not sponsor individuals for employment visas, now or in the future, for this job opening.

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