Reagent Manufacturing Project Manager

Description

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture as a Reagent Manufacturing Project Manager!

Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
• Leads and monitors projects throughout development, initiation, planning, execution, control and closing. 
• Acts as the point of contact and expert for assigned projects.
• Develop risk assessment, specifications, validation plans, protocols and reports that support the qualification and validation of manufacturing processes.
• Develop and maintain accurate timelines for multiple projects.
• Plan and oversee the implementation of new and/or improved manufacturing processes and equipment
• Schedule meetings, create agendas, documents meeting minutes, correspondence, and presentations
• Communicates, prepares and presents reports, summaries and analysis to support the project and status of projects. 
• Creates and maintains relevant project documentation throughout the project.
• Applies project management best practices throughout the project lifecycle
• Investigates, creates, and develops new methods and technologies for project advancement.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Promote QSR and regulatory compliance into assigned projects.

Studies and Experience:

• Minimum of Bachelor’s degree in related scientific or engineering field.
• Minimum two years in project management is desired.

Skills and Qualifications:

• Knowledge of validation strategies as they pertain to the medical device manufacturing industry
• Ability to relate with people at all levels within an organization
• Must work well independently as well as in a team environment
• Must be an effective communicator
• Must be able to work on multiple projects simultaneously