Senior Project Manager BTO - Med Dev Product Devel

at The Jackson Laboratory in Bar Harbor, Maine, United States Job Description We are currently seeking a skilled & passionate individual who is eager to contribute to our mission and accelerate drug development by delivering translationally relevant mice, stem cells, services, and system platforms - including AI Software. If you're ready to make a difference and be part of a team that's at the forefront of preclinical drug development, JAX is the place for you. Our global footprint and state-of-the art facilities offer an unparalleled opportunity to work with top-tier scientists, R D team members, study directors, and researchers in a dynamic and collaborative environment. Join us at JAX and help shape the future of human health. This role can be fully remote with travel as needed!! About the job The Senior Project Manager will play a key role in supporting new product development & innovation projects within the new Business Transformation Office (BTO). The BTO has a combined focus on strategic projects, innovation projects, and mergers & acquisition projects supporting JMCRS (JAX Mice and Clinical Research Services) as well as JAX organizational growth. This role will contribute proactively to the success of the innovation portfolio by deploying project management professional skills in waterfall planning, agile scrum execution, and other Lean principals. This role will require strong working knowledge of a medical device or life sciences product development processes, drawing from past experience in FDA and

ISO 13485

Design Controls in a Stage Gate model. At the same time, a high degree of business acumen is required to drive robust decision making to drive incremental revenue generation via new product launch. This is a traditional matrix management role, with no direct reports, but close ties to the Product Management, R D, Operations, Quality, and Finance team members. The Senior Project Manager will also be supported by the BTO Resource Manager. Key Responsibilities Owns the existing Stage-Gate project lifecycle SOP with templates (deliverables) Applies project lifecycle to a portfolio of projects leading to on-time completion. Presents project status, in partnership with Product Manager, at each Gate Review Meeting to drive project progress and on-time launch. Elicits project requirements from stakeholders and leads project scoping & chartering to initiate projects. Utilizes project change control to track changes of project scope. Utilizes best practice requirements traceability matrix to collect requirement test plans, acceptance criteria, and actual test results from project team members to ultimately determine which requirements have been met and those which remain unmet at any given time. Leverages past experience to help project team members understand the difference between verification testing and validation testing, and when to apply each. Leads Kaizen-style project master planning events ("walk the walls") to develop visual master schedules, identify critical path, assign risk buffers, and track projects through on-time launch. Employs agile-scrum methodology for project micro planning and daily execution to ensure timely progress on project actions, deliverables, and milestones. Conducts resource demand analysis, based on project master plan and micro plan, to request resources from steering committee on a regular basis. Provides regular portfolio updates to executive leadership including resource utilization and status of key milestones through dashboards and metrics. Leverages past experience to help project team members predict product, process, and/or project risks, and develop appropriate mitigation strategies. Applies financial acumen and works with Product Manager and Finance Team Member to develop Net Present Value (NPV), Discounted Cash Flow (DCF), and/or Return on Investment (ROI) models. Leverages and utilizes best practices, key specific frameworks and best in class industry tools to improve project planning, management, and risk mitigation throughout execution and value delivery, including post-mortem review. Collaborates with key stakeholders to drive key process initiatives to enhance effectiveness in project management processes, governance, resource planning and portfolio management. Standardizes project management levels of services, frameworks, tools and key performance indicators to enable project success. Knowledge, Skills, And Abilities 10+ years as a career project/product/program manager with specific experience in driving complex, long-term, strategic projects consuming many cross-functional resources. 3+ years FDA and/or

ISO 13485

Product Development project management experience from a well-established benchmark Medical Device or Life Sciences... For full info follow application link. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. To view full details and how to apply, please login or create a Job Seeker account