Reagent Technical Project Manager III

1 Month ago • 5 Years + • Project Management

Job Summary

Job Description

The Technical Project Manager will be responsible for leading reagent projects within manufacturing, collaborating with operations, engineering, and continuous improvement leaders. This role involves creating project documentation and ensuring projects are implemented on schedule and in compliance with design control and QMS requirements. The position requires regular project updates to leaders and stakeholders, performing work in compliance with company policy and BioFire Diagnostics’ Quality System, and leading projects with significant scope, scale, and complexity throughout their lifecycle. Key duties include writing project plans, creating project management deliverables, overseeing the implementation of new manufacturing processes and equipment, developing risk assessments and validation plans, leading project teams, facilitating communications, monitoring project performance, and maintaining quality documentation. The role also emphasizes applying project management best practices, promoting Quality System Regulations (QSR) and regulatory compliance, investigating new methods for project advancement, tailoring best practices to assigned projects, conducting risk assessments, and potentially mentoring other project managers.
Must have:
  • Bachelor's degree in a scientific field
  • CAPM or PMP certification
  • 5 years of project management experience
  • 2 years of relevant industry experience
  • Knowledge of validation strategies in medical device manufacturing
  • Ability to relate to people at all levels
  • Work well independently and in a team
  • Manage multiple projects simultaneously
  • Effective and respectful communication with stakeholders
  • Adapt to changes with resilience

Job Details

Description

Position Summary 

This position is located in Salt Lake City, Utah and would be expected to report onsite at this location.


The Technical Project Manager is assigned to projects within Reagent Manufacturing.  This individual will collaborate with various leaders within manufacturing including operations, engineering, continuous improvement and other subject matter experts to create project documentation and implement projects on schedule as well as within accordance with design control and QMS requirements.  In addition to meeting regularly with assigned project resources, this individual is also expected to provide regular project updates to leaders and stakeholders within the organization.

Primary Duties 
1.    Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System
2.    Lead Reagent projects with significant scope, scale, and complexity throughout the project lifecycle 
3.    Write project plans to document project scope, resources, timeline, risks, and detailed phases
4.    Create project management deliverables for assigned projects, including developing and maintaining accurate project timelines 
5.    Oversee the implementation of new or improved manufacturing processes and equipment that deliver value to the Reagent Manufacturing and BMX
6.    Develop or oversee the creation of risk assessments, specifications, validation plans, protocols, and reports that support the qualification and validation of manufacturing processes
7.    Effectively lead project teams through identifying, creating, and tracking deliverables in a motivating and collaborative manner to drive the project to completion
8.    Schedule meetings, create agendas, circulate meeting minutes, facilitate project communications, and deliver presentations 
9.    Monitor and communicate project performance through periodic reporting
10.    Create and maintain relevant quality documentation throughout the project
11.    Apply project management best practices throughout the project lifecycle
12.    Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. 
13.    Promote Quality System Regulations (QSR) and regulatory compliance into assigned projects
14.    Investigate, create, and share new methods and technologies for project advancement
15.    Effectively tailor project management best practices and processes to assigned projects based on context
16.    Conduct project risk assessments and determine risk mitigations and responses with the project team
17.    Lead projects that may require overseeing the execution of sub-projects led by other project managers 
18.    May mentor, lead, and train other Reagent Project Managers

Education and Experience
•    Bachelor’s degree related scientific field
•    CAPM or PMP certification

•    5 years of project management experience
•    2 years of relevant industry experience

Knowledge, Skills, and Abilities
•    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 effectively in a team environment
•    Must be able to work on multiple projects simultaneously
•    Must be an effective and respectful communicator with project stakeholders
•    Must be able to adapt to changes in projects and priorities with resilience 
•    Ability to manage cross-functional projects and effectively engage with many types of stakeholders, internal and external to Reagent Manufacturing

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