Are you interested in an engaging job and making a big impact in patient's lives?
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
- 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
- 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
Windgap Medical, Inc. offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan 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.
Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.
The Windgap Medical Team