Strategic Program Coordinator

At BioFire Defense, our workplace is as vibrant as our mission: casual vibes, intense execution, and a passion for IMPACT.

The Strategic Program Coordinator will play a key role in establishing and orchestrating enterprise-level project management, contract manufacturing product development, and process improvement capabilities in support of company and corporate strategic objectives aimed at transforming the organization. The position coordinates transversal, multidisciplinary project management activities involving key affiliates, including BioFire Diagnostics (BFDx) and bioMérieux (bMx), and across multiple departments within the organization. These initiatives span new commercial product offerings, continuous improvement, operational streamlining, life cycle management, and system modernization, requiring structured governance and seamless integration across entities. This role will foster collaboration and communication across different groups and teams to ensure alignment with the transformation goals while working closely with leadership.

The qualified individual will be responsible for high-level coordination and management of stakeholder decisions/communications for efforts related to the planning, oversight, and management of projects and other assisted duties on behalf of the company in conjunction with applicable cross-functional groups (i.e., Manufacturing, Systems Integration (SI) Regulatory, Quality Assurance (QA), Research & Development (R&D), Finance, Sales & Marketing, Software, Facilities, and affiliates.). This role will assess and mitigate risks associated with the transformation process including identifying potential obstacles, developing contingency plans, and ensuring organization readiness to navigate challenges. This role will also foster a culture of continuous improvement by regularly evaluating the effectiveness of transformation efforts and making need adjustments based on feedback.

The Strategic Program Coordinator will work closely with representatives from other relevant groups to manage the development and implementation activities for operational processes, procedures, and workflows associated with the transfer of new products, processes, or components into the BFDf product portfolio. Additionally, this position will also manage and provide support in lifecycle maintenance/sustainment efforts (e.g., CAPAs, product changes, labeling changes, process changes, etc.) associated with existing products throughout each product's lifecycle to maintain compliance.

The Strategic Program Coordinator will be responsible for communication regarding critical decisions in product or process inputs and risks, risks, project timelines, etc. to support project and organizational deliverables (e.g., WIDs/SOPs, batch records, flow charts, technical reviews, heat maps, project status updates, etc.). The Strategic Program Coordinator will also provide oversight and support of deliverables throughout the validation and QMS approval processes, and provide updates as needed to relevant project stakeholders. This role may mentor others on the team and may manage as applicable. This role should be available for external audits.

Principal Job Duties and Responsibilities:

• Lead and coordinate transversal projects across BFDf, BFDx, and bMx, ensuring alignment with strategic transformation objectives and organizational priorities. Drive process and product improvement initiatives that deliver measurable impact (e.g., COGS optimization), while ensuring compliance with quality and regulatory requirements.

• Establish and maintain project management standards, including consistent planning, resource allocation, execution tracking, and accountability for measurable outcomes.

• Monitor and communicate the status of intercompany and intracompany projects, improving visibility, productivity, fiscal discipline, and organizational alignment. Report progress against company strategic objectives using dashboards, heat maps, and standardized reporting tools.

• Support S&OP efforts by reporting on life cycle management aspects of intercompany and intracompany projects including changes to product, obsolescence, configuration management, and product release.

• Partner with cross-functional stakeholders to support contract manufacturing objectives and leverage best practices across the enterprise.

• Prepare and lead high-level project agendas and meetings focused on process validation strategies, risk assessments, and workflow determination.

• Identify and communicate critical risks regarding manufacturing inputs, process changes, and project timelines to relevant stakeholders.

• Monitor functional aspects of projects, including budget, scope and timeline as required.

• Identify, recommend appropriate responses and solutions, and facilitate resolution of issues.

• Prepare technical reviews, summaries, protocols, as requested.

• Review design documents for compliance and consistency. Participate in interdepartmental and cross-functional Design Teams with little to no oversight. Proficient in BFDF Design Control and Risk Management concepts. Propose strategies for products with little oversight.

• Enhance technical writing standards across the organization, ensuring documentation is clear, accurate, compliant, and aligned with industry expectations.

• Lead, track, and coordinate communications with BFDf, BFDx, and bMx Change Control Boards, ensuring alignment on approvals, implementation, regulatory actions, and/or QMS updates. May authorize changes and assessments of changes.

• Develop and implement clear RACI (and DACI, where applicable) frameworks for internal and group revenue processes to define ownership, accountability, and decision-making authority.

• Establish and enforce best practices for external stakeholder engagement, including:

• Distribution of pre-read materials (agenda, data, and position)

• Internal alignment and calibration prior to meetings to ensure unified messaging

• Issuance of post-meeting recaps and action logs, including owners and due dates

• Identify and implement opportunities to streamline operations, eliminate inefficiencies, and support scalable, sustainable growth.

Benefits:

Medical

Dental

Vision

Bonus eligible

9/8/80 work schedule (every other Friday off)

401k - company match of 5% regardless of participation and up to a total of 9.5% company match if contributing

160 Hours of PTO (prorated from date of hire)

9 Paid Holidays

Paid Winter Break from the work week between December 24 thru December 31

Participation in Companys Wellness Program (discounted medical premiums)

Multiple Company Sponsored Events Each Year (catered breakfast/lunch, holiday parties, snacks)

Convenient location near I-15 and Trax Station

Free Parking

Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.