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Direct Supervisor: VP of Operations

Description and Responsibilities

Position Summary:

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 preventative 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. In this role the Operations Reliability Scientific Director will be responsible for actively identifying and implementing process improvement opportunities. A key element of the role will be routinely interfacing with the R&D groups to proactively identify trends, potential failure modes, and risks associated with production events. This individual will lead a team responsible for oversight and execution of the duties and responsibilities hereto outlined.

Principal Job Duties and Responsibilities:
1. Works on problems of diverse scope in which the analysis of data requires the evaluation of identifiable factors to aid in the proactive identification of potential trends or failure modes that may be determinantal to product performance.

2. Leads or participates in product reliability investigations related to reagent manufacturing (Quality Events, SPC trends, project-related) that may have significant on product performance and business operations.

3. Initiates and leads CAPAs related to manufacturing for product reliability performance issues internally and externally. Leads root causes analysis and assists in applying corrective and preventative actions.

4. Interacts and engages cross-functionally with other departments during the investigation and resolution process, and for process improvement projects.

5. Identify and report on existing and emerging trends, and investigations related to process and product performance to the Operations and Defense Leadership Teams. Also, including but not limited to, BSI, FDA, Post Market, Regulatory bodies, internal auditors, and Post Market as requested.

6. Identify and report on existing and emerging trends, investigations, and quality events related to processes and products performance to the Operations management, and Defense Leadership Teams.

7. Manages departmental metric data related to the product performance process and reports on metric data to various operational and product performance-related stakeholder groups.

8. 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.

9. 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.

10. Provides process and product technical guidance to program managers and engineers, including training/mentoring manufacturing leaders.

11. Leads the Operations department as the technical expert on reagent chemistry interactions.

12. This position requires the individual to act as the primary, technical, liaison between R&D, Regulatory, Quality, and manufacturing operations departments.

13. Attends project phase gates as needed and reviews project plans that have process and product impact.

14. Performs all work in compliance with company quality procedures and standards.

15. Identifies and implements, with the aid of the Industrialization and Tech transfer team, process improvement opportunities.

16. Administrates, Manages, and leads a team whose primary focus is product reliability, process improvement, and the early identification of potential product performance issues related to processes, personnel, environment, raw materials, and automation interfaces. The team will be responsible for acquiring technical acumen and expertise for all areas underneath eh Operations umbrella.

17. Performs other duties as assigned

Qualifications

Training and Education:  (Minimum education and/or training requirements for this position; i.e., high school diploma, college degree, certification.)

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

Experience:  (Minimum time and type experience required for this position.)

• 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
• Six Sigma certification preferred
• First author publication preferred

Skills:   (Special skills required; e.g., negotiation, technical writing; statistical evaluation.)

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

Physical Requirements:  (List any special physical requirements needed to perform the job, such as ability to lift specific weight.  List “None” if there are no special requirements.)

None

Review

I have reviewed this job description with my supervisor.  I understand my responsibilities and I meet the minimum requirements listed above.  I have provided BioFire Defense’s Human Resources Department with documented evidence (i.e. resume, copies of diplomas, letters of employment verification) that I meet the above-listed qualifications.