BioFire Diagnostics is seeking a Senior Manager who will be responsible for the daily work in the designated manufacturing areas of the BioReagent Formulation group including oversight of the people, processes, and product.

　　Principal Job Duties and Responsibilities:

　　Perform all work in compliance with company policy and within the guidelines of Biomerieux's Quality System.

　　People:

　　Supports leadership team across multiple shifts and/or locations, and is expected to be available outside standard work hours.

　　Supports supervisors with complex Human Resource issues such as company-paid leave, accommodations, and terminations.

　　Execute staffing and equipment scheduling plans across multiple shifts and/or locations.

　　Approves and coordinates transfers across shifts and locations within the manufacturing division.

　　Ensure training and proficiency is standardized across shifts and/or locations.

　　Where supervisors are not part of the organizational structure or when a supervisor is unavailable, the manager serve the additional role:

　　Provide direct management of the production team assigned to the shift. Responsible for basic corrective action such as attendance, behavior, and performance and consults with the manager for more complex human resource issues such as company-approved leave and accommodations.

　　Responsible for interviewing and hiring personnel for the assigned shift.

　　Responsible for timesheet approval, PTO approvals, timesheet approval and attendance tracking.

　　Responsible for assisting Technical leads & Team leads with technical issues such as training, organization workflow, and troubleshooting production issues. Works with team to adapt to changes affecting daily production schedule to ensure available team resources can meet planned production

　　Product:

　　Coordinates and resolves non-standard events such as scheduling issues, downtime, or non-conformance events that span multiple shifts or locations.

　　Reviews and approves disposition of non-conforming production events. Works with the area Director or Associate Director on non-standard, more complex NCRs.

　　Writes and oversees rework procedures in accordance with the Quality Management System.

　　Where supervisors are not part of the organizational structure or when a supervisor is unavailable, the manager serve the additional role:

　　Provide on time delivery of products by executing production schedule, and by resolving process/product related issues using tools such as Temporary Deviations, rework procedures, NCR’s, etc.

　　Responsible for working with engineering and QA on quality investigations including problem identification, corrective actions, data review and analysis and timely completion of documentation.

　　Responsible for overseeing all in-process testing in the pouch and array areas and ensuring the control plan is being followed as documented.

　　Ensure that R&D orders are completed correctly by communicating and clarifying special instructions to the team as necessary.

　　Processes:

　　Ensures production process is standardized across multiple shifts and/or locations.

　　Monitors performance across multiple shifts and/or locations and works with area leadership to resolve issues.

　　May serve as the manufacturing lead in projects and initiatives assigned to the division.

　　Where supervisors are not part of the organizational structure or when a supervisor is unavailable, the manager serve the additional role:

　　Work closely with Operations management to identify and implement improvements to manufacturing processes.

　　Serves as technical expert and contributes to decisions regarding developmental and process improvement initiatives such as automation, workflow design, and 6S.

　　May serve as a member of the BERT team and/or safety committee.

　　Perform additional duties as assigned by management

　　Training and Education

　　Bachelor’s degree/4 year program with an emphasis on a biological science required.

　　Experience

　　Minimum of 2 years in regulated manufacturing environment with a minimum of 3 years in a leadership role. Preference given to internal candidates with experience in manufacturing. Experience in industry and knowledge of FDA and ISO 9001 and 13485 preferred.

　　Knowledge, Skills, and Abilities

　　Well-developed interpersonal communication and team leadership skills. Must be able to communicate and collaborate with direct reports as well as cross-functional colleagues.

　　Ability to organize, lead and evaluate the work of other personnel.

　　Ability to address and resolve employee performance and behavioral issues in a professional manner.

　　Exhibit a high level of organization and tremendous attention to detail.

　　General computer literacy spreadsheet word processing software.

　　Basic math skills.

　　Ability to write reports, manufacturing procedures, and training material.

　　Ability to define problems, collect data, establish facts, and draw valid conclusions.

　　Ability to communicate clearly in both written and oral formats.