Senior Project Manager BTO - New Product Development, Med Device- Fully Remote!!!

We are growing! The Jackson Laboratory (JAX) has expanded capacity at a new state-of-the-art preclinical facility located at Momentum Labs in Gainesville, Florida.

We are currently seeking passionate individuals who are eager to contribute to our mission and accelerate drug development by delivering translationally relevant preclinical services.

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 new facility offers an unparalleled opportunity to work with top-tier scientists, study directors, and researchers in a dynamic and collaborative environment.

Join us at JAX and help shape the future of human health.

Learn More Here -

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 the building of standardized product development processes, drawing from past experience in FDA and ISO 13485 Design Controls in a Stage Gate model.

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 be a teacher of Design Controls across the business, including mentorship to other project managers.

The Senior Project Manager will also be supported by the BTO Resource Manager.

Key Responsibilities

Creates & trains project lifecycle with appropriate deliverables in each Stage and approval criteria for each Gate. 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 completion of studies.

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 organization.

Bachelor’s of Science in Engineering or Marketing preferred, MBA preferred

Global customer facing project management experience (e.g. managing projects / customers in multiple countries).

Demonstrated experience building & implementing best practices from scratch.

Knowledge of FDA Design Controls required.

Working knowledge of ISO 13485, ISO 9001, and / or AS9100 required, auditee preferred.

Demonstrated experience being an agent of change with proven track record of influence and driving required operational change.

Demonstrated ability to successfully implement a project management framework that drives consistency and operational excellence.

Experience working in matrixed and complex organizations and an appreciation of how to execute in a high growth, fast paced environment.

Previous Lean, Continuous Improvement and / or Transformation experience preferred.

Microsoft Project experience required, experience with other PM or Agile software preferred

Pay Range : $111,488 - $186,656 based on total years or prior relevant experience

CA-JO2

About JAX :

The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California), Japan and China.

Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.

Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease.

It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community.