Operations Reliability Scientist

Job Description

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

Job Title:

Operations Reliability Scientist

Direct Supervisor: VP of Operations

The Operations Reliability Scientific Director will be responsible for overseeing data, investigations, and information associated with product performance within the Operations Department. The role will lead cross‑functional teams for product failure investigations to determine potential product impact, identify root causes, and assist in implementing corrective and preventive actions in accordance with established procedures. This role monitors and reports on product trends for various operational and product performance‑related stakeholder groups and provides technical guidance on product and process risk to other support and project teams.

It also actively identifies and implements process improvement opportunities and routinely interfaces with the R&D groups to proactively identify trends, potential failure modes, and risks associated with production events.

• Works on problems of diverse scope where data analysis requires evaluation of identifiable factors to aid in proactive identification of potential trends or failure modes that may be determinantal to product performance.
• Leads or participates in product reliability investigations related to reagent manufacturing (quality events, SPC trends, project‑related) that may have significant impact on product performance and business operations.
• Initiates and leads CAPAs related to manufacturing for product reliability performance issues internally and externally; leads root‑cause analysis and assists in applying corrective and preventative actions.
• Interacts and engages cross‑functionally with other departments during the investigation and resolution process, and for process improvement projects.
• Identifies and reports on existing and emerging trends, and investigations related to process and product performance to the Operations and Defense Leadership Teams, including but not limited to BSI, FDA, post‑market regulatory bodies, internal auditors, and post‑market as requested.
• Manages departmental metric data related to the product performance process and reports on metric data to various operational and product performance‑related stakeholder groups.
• Uses technical writing and presentation skills to provide product knowledge and recommendations regarding product non‑conformances, and other investigations in accordance with the Quality Management System.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions; normally receives little instruction on routine work and general instructions on new assignments.
• Provides process and product technical guidance to program managers and engineers, including training/mentoring manufacturing leaders.
• Leads the Operations department as the technical expert on reagent chemistry interactions.
• Acts as the primary technical liaison between R&D, regulatory, quality, and manufacturing operations departments.
• Attends project phase gates as needed and reviews project plans that have process and product impact.
• Performs all work in compliance with company quality procedures and standards.
• Identifies and implements process improvement opportunities with the aid of the industrialization and tech transfer team.
• Administrates, manages, and leads a team whose primary focus is product reliability, process improvement, and early identification of potential product performance issues related to processes, personnel, environment, raw materials, and automation interfaces.
• Performs other duties as assigned.

• MS degree in Biochemistry, Chemical Engineering, or other science‑related program required.
• PhD degree in Biochemistry, Chemical Engineering, or other science‑related program preferred.

• 4-5 years’ experience in troubleshooting, project planning, completion, execution, scientific rigor, investigation, and process improvement.
• Familiarity within a QMS, regulatory, cGMP environment.
• Experience as a Project or Program Manager preferred.

Technical writing, statistical evaluation, data analytics, critical thinking, analytical skills, problem‑solving skills.

None.

Bio Fire Defense is an equal‑opportunity employer (M/F/D/V) and complies with applicable state and local laws governing non‑discrimination in employment in every location. 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.

Bio Fire Defense, LLC, 79 West 4500 South, Salt Lake City, Utah, United States of America