Position

Status

Department

Position Summary:

The Program Manger will work with representatives from all functional teams (Engineering, Chemistry, R&D, Software, Production, Quality, Sales) and manage the development and introduction of new products as well as managing the current product suite. Gaining an intimate knowledge of these instrumentation and reagent products/projects is critical to meeting launch deadlines and managing fielded products.

• Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System and FDA GMP/Design Control Systems.
• Develops and executes integrated cross-functional plans for projects throughout development, initiation, planning, execution, control and closing of projects while adhering to Budget, scope and schedule requirements.
• Coordinates activities between R&D, Marketing, Manufacturing, and Regulatory organizations.
• Implements and communicates the strategic and technical direction for the product/project team.
• Works with Program Director to identify customer needs for specific projects and programs and manage their development and execution.
• Works closely with corporate development to develop overall product launch plan.
• Identifies any issues that may delay product or project and recommends appropriate action to be taken. Facilitates appropriate resolution.
• Facilitates and manages internal and external meetings.
• Helps ensure consistent practices throughout all phases of the project life cycle.
• Prepares technical reports, summaries, protocols, and Design Control documents.

Training and Education:

• Requires a B.S. in life science, engineering or equivalent technical field.
• 5 years’ experience minimum in technical project management, preferably managing projects spanning instrumentation and/or chemistry products. Experience with Government contracting is a plus.
• Experience in the Life Science industry and/or in PCR is a plus.
• Experience with cGMP, ISO and FDA regulations is a plus
• Must have significant organizational skills and be able to create and manage detailed documentation, timelines and performance metrics.
• Must be able to successfully manage people of various technical backgrounds.
• Ability to manage and track detailed schedules in MS Project.
• Negotiating and effective communication skills required.
• Attention to critical detail and project specifications.
• Fluency in French a plus.

Benefits and Compensation

• We offer competitive salaries
• 401k
• Vacation/holiday pay
• Medical benefits
• Stimulating work environment