Manufacturing Operations Production Manager

Position Summary:

The Manufacturing Operations Production Manager is responsible for coordinating all aspects of day-to-day manufacturing operations across assigned work centers. This manager is accountable for safe, compliant, and timely execution of the production schedule; personnel leadership and development; work-center readiness; inventory and material control; manufacturing output; technical troubleshooting; quality investigations; and continuous improvement.

This position supports the following work centers and activities:

Pouch Line Consumable Production

Subassembly production of arrays and pouch film

RAZOR pouch line consumable production

  This individual will work closely with production engineers, line leads/supervisors, quality, and associate director of reagent manufacturing. The manager provides guidance for the assigned work centers and personnel staffing these work centers. The manager is expected to report to the associate director and director, when applicable. It is expected that each work center will complete the scheduled task assigned to each work center. If work centers are not directly scheduled by the scheduling team, the manager with ensure parts are made in advance and will meet the scheduling needs of the company. On-time deliver is enforced and expected. This individual will be responsible for ensuring that all products are manufactured in compliance with the BioFire Defense quality system.  This individual will work closely with upper management to identify and implement improvements to manufacturing processes.  A high level of organization and tremendous attention to detail is essential to successfully manage this group.  They will be assigned NCRs and be expected to investigate, support, and close NCRs in a timely manner. There will be times when CAPA support will be essential and needed to meet company objectives of root cause and improvement to the process to avoid further issues. This person will support new equipment, new products, new restraints, and onboarding of new people. Training, expertise and foresight will be required for this position.

Principal Job Duties and Responsibilities:

Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System.

Lead daily operations across assigned manufacturing work centers and remain accountable for production personnel, work-center readiness, manufacturing output, and schedule execution.

Translate production demand into daily, weekly, and monthly priorities; assign personnel and equipment; monitor progress; and adjust resources to address changing business needs.

Manage, coach, and develop production personnel, including work assignments, schedules, attendance, training, performance feedback, performance reviews, and corrective action in accordance with company policy.

Ensure personnel are trained and qualified before independently performing assigned manufacturing processes and maintain adequate cross-training to support operational coverage.

Monitor production output, backlog, quality, scrap, rework, labor utilization, and other relevant measures; communicate risks and constraints; and take appropriate action to protect delivery commitments.

Oversee work-center inventory, KANBAN levels, safety stock, raw material requirements, and scrap for parts and chemicals; approve or request purchases within assigned authority.

Provide direction and troubleshooting support for manufacturing processes and supporting instrumentation, as applicable.

Lead or support investigations of NCRs, deviations, process failures, and product-related issues; contribute to root-cause analysis, CAPA development, and implementation of corrective and preventive actions.

Create, revise, and maintain procedures, work instructions, manufacturing records, and other controlled documentation in compliance with regulatory requirements and Good Manufacturing Practices.

Sustain efforts in the area of responsibility and organization.  Develop a thorough understanding of the assigned production areas to identify improvement opportunities.

Maintain records in compliance with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.

Act as a catalyst for positive change.

Accurately appraise strengths and weaknesses, provide constructive feedback, reinforce individual and team performance. 

Perform cycle counts of WIP and reconcile with inventory system to ensure accurate inventory, where applicable.

Maintains ongoing analysis of key issues, projects and objectives and provides regular reports that include metrics to summarize the status and trends of key operations parameters.

Identify and implement improvements to safety, quality, throughput, capacity, workflow, inventory control, scrap, and labor utilization within assigned areas.

Represent the department in cross-functional meetings, communicate operating status and resource needs, and support the Director, Reagents Manufacturing, with department priorities and assigned initiatives.

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

High School Diploma and 7 years related experience. 

Experience in manufacturing and biotechnology fields using cGMP/QSR/ISO regulations required. 

*Preferred to have a bachelor’s degree in life science, but not a requirement.

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

Knowledge of real time PCR is preferred. 

Experience in biotech industry

Knowledge of GMP/QSR/ISO is a plus.

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

• Demonstrated ability to lead, coach, develop, and hold employees accountable.

• Production planning, scheduling, prioritization, and resource-allocation skills.

• Demonstrate troubleshooting and structured root-cause investigation skills.

• Ability to interpret manufacturing and quality-control data and make decisions within established procedures and specifications.

• Working knowledge of Good Manufacturing Practices, controlled documentation, NCRs, CAPAs, and change-control processes.

• Strong technical writing, organization, communication, conflict-resolution, and cross-functional collaboration skills.

•Ability to manage competing priorities, identify operational risk, and communicate issues and recommendations clearly.