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.

Required:

• Bachelor's degree in Chemical Engineering, Coating Engineering, or related field.
• 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 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, verification and validation, manufacturing and testing activities.
• Experience with Lean Manufacturing, Six Sigma, or similar methodologies.
• Strong leadership and team-building abilities.
• Excellent problem-solving and decision-making skills.
• Effective communication across all levels of the organization.

Preferred:

• Masters Degree
• Experience in a regulated industry (pharmaceutical, medical device)
• Certification in Lean Six Sigma (Green Belt or higher)

Internal Partners:

Director, Manufacturing - collaborate on development of strategic and tactical metrics. Collaborate on the development of manufacturing strategies. Execute continuous improvement activities in support of agreed strategic actions.

Quality - Communicate manufacturing strategies so that they may provide guidance and support to manufacturing, thus ensuring quality processes and products. This includes collaborating on development of inspection control plans and quality system controls to support manufacturing operations.

Planning/Supply Chain - Communicate technical difficulties, manufacturing roadblocks, capacity issues, and continuous feedback on performance to the manufacturing plan. Collaborate on inventory, production planning, material handling, purchasing and space allotment plans and policies.

Finance - Review financial reports, provide feedback on results, work to improve timeliness and accuracy of information. Monitor and implement MUV and Scrap reduction efforts.

Production Supervisor, Process Engineers and Quality Engineers - Mentor, direct, and inform managers concerning the vision and mission of the department. Provide managerial support based on each individual's management requirements, and ensure operation's success by providing necessary tools.

Facilities - Ensure information on production requirements relating to production equipment. Collaborate on short and long term plant layout plans.

External Partners:

R&D - Ensure support for R&D projects and provide resources as required.

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time you will be…