Position Summary:
- BioFire Defense, LLC, is looking to hire a Project Manager. The Project Manager works with corporate functional teams to manage new product development, internal operations projects, and existing product maintenance. In the execution of corporate projects, the PM is responsible for maintaining, tracking, and recording tasks, schedules, and budgets for the functional teams. The PM is also responsible for project documentation within the framework of contractual, regulatory, and quality guidelines for all projects.
Principal Job Duties and Responsibilities:
- 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 team meetings, both internal and external.
- Helps ensure consistent practices throughout all phases of the project life cycle.
- Prepares technical reports, summaries, protocols, and Design Control documents.
Training and Education
- B.S. in life science, engineering, or equivalent technical field.
Experience/Skills/Physical Requirements:
- 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 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 manage people of various technical backgrounds successfully.
- Ability to manage and track detailed schedules in MS Project.
- Negotiating and effective communications skills required.
- Attention to critical detail and project specifications.
Benefits/Compensation:
- We offer competitive salaries
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment
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