Senior Manager, Film Coating Operations

The Opportunity

Quidel Ortho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to THRIVE as Quidel Ortho, we are seeking a Senior Manager, Film Coating Operations. The Senior Manager of Film Coating is responsible for leading and optimizing all aspects of film coating operations within the manufacturing environment. This role ensures consistent product quality, operational efficiency, regulatory compliance, and team development. The ideal candidate brings deep technical expertise in film coating processes, strong leadership capabilities, and a continuous improvement mindset "Change Agent".

The Senior Manager is responsible for leading a multi- shift supervisor team empowered to manage a 24x5 schedule and transitioning to a 24x7 schedule.

This position is in Rochester, NY.

• Operational Leadership: Oversee daily operations of the film coating department, ensuring adherence to production schedules, quality standards, budget, and safety protocols. Need for a significant EHS safety upgrade and environmental compliance plan with related experiences
• Process Optimization: Drive continuous improvement initiatives to enhance coating uniformity, throughput, and yield while reducing waste and downtime. Utilize formal problem solving tools AND the need to “problem” solve and implement solutions to problem chemistries. Requires knowledge of process capabilities and performances related to coating and slitting processes.
• Technical Expertise: Make analytical based production decisions for film coating technologies, equipment and formulation interactions.
• Cross-Functional Collaboration: Partner with R&D, Quality Assurance, Engineering, and Supply Chain to support new product introductions, process validations, and troubleshooting.
• Regulatory Compliance: Ensure compliance with cGMP, FDA, OSHA and other applicable regulatory standards.
• Team Development: Lead, mentor, and develop a team of supervisors, operators, and technicians. Foster a culture of accountability, safety, and continuous learning. Manage performance of the team.
• Capital Projects: Support or lead capital investment projects related to coating equipment upgrades, facility expansions, or automation initiatives.

Required:

• Bachelor’s degree in Chemical Engineering, Coating Engineering, or related field, equivalent work experience will be considered.
• Minimum 8–10 years of experience in operations, with at least 3–5 years in a leadership or managerial role.
• Knowledge of coating processes and formulation.
• Excellent skills in MS Office (MS Word/Excel)
• Excellent Good Manufacturing Practice (GMP) knowledge.
• Experience in understanding and adhering to manufacturing documentation, and completing manufacturing documentation.
• Experience in managing the operation of equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations.
• Strong technical writing and analytical skills required to write investigative reports, SOPs, NCMRs, batch records and other production-related documents.
• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
• Has awareness of device defects that may occur in their area of responsibility, including product design,…