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
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment