25 days old

Project Manager

Windgap Medical, Inc.

Watertown, Massachusetts 02472

Apply Now

Job Type
Employee
Job Status
Full Time
PMP® Certification Preferred
CAPM® Certification Preferred

Windgap Medical, Inc. is a rapidly-growing, private pharmaceutical company developing injection devices for self-administration and associated drugs. Windgap’s first product is a wet/dry autoinjector delivering a proprietary epinephrine formulation for the treatment of anaphylactic shock. Long-term, Windgap will leverage its injection platform for additional indications.

Windgap is seeking a hands-on project manager to support the effective and efficient development and release of our products. Windgap leverages a team of Contract Manufacturing Organizations (CMOs) for all manufacturing operations. Windgap is transitioning from product development and pilot production into a full production environment with these same CMOs. The candidate should be a flexible, self-starter, who is effective at managing in situations where they are held accountable in a multi-stakeholder environment. They should also be comfortable investigating and executing a wide variety of tasks. The position is focused upon the tracking and management of Company’s major projects, driving and communicating schedule, budget, and performance to stakeholders both inside and outside of the Company.

Role - The Candidate will:

report to Windgap’s VP of Operations
be responsible for the project management and project-related reporting functions
understand the operational relationships between internal and external contributors and communicate project information with and between Windgap and CMO project management resources
maintain and update the primary project documents containing GANTT and cost information to ensure current cost and schedule information
develop relevant KPIs to ensure a timely understanding of both project and financial performance
effectively communicate the cost/time/risk impact of decisions on project deliverables
support the growth of relationships with both current and new assets through positive, timely communication
work with all key stakeholders to ensure high-quality and timely, volume production

Requirements

BS or equivalent experience required, background in sciences, or technology preferred
At least 3 years of both hands-on and management success in project management of medical device and/or pharmaceutical programs
Experience managing projects in highly virtualized organizations, successfully engaging and managing external resources, worldwide
Experience in using a software-based project management tools to successfully bring a product into high-volume production
Experience in a start-up environment, requiring flexibility along with the ability to seek out and quickly assimilate new information
Very preferably, a background in engineering
Preferably, experience with managing drug/device combination products development
Preferably, experience functioning within 21 CFR 210, 21 CFR 211 and 21 CFR 820
Preferably, certification in project management such as PMP or PgMP
Preferably, an understanding of costing and finance
Experience with MS Office, including email, word processing, spreadsheets, project management and presentation tools

Salary Details

Windgap Medical, Inc. offers a competitive compensation and benefits package including, medical, dental, disability, life insurance, 401K savings plan, stock options, and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Windgap's corporate headquarters are in Watertown, MA. Employees based out of this office must be willing and able to be in the Watertown office when it is safe to do so, per company, State, and Federal COVID-19 guidelines.