Senior Manager, Film Coating Operations

The Opportunity

QuidelOrtho 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.

The Role

As we continue to THRIVE as QuidelOrtho, 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.

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Responsibilities

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.

The Individual

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 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, 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)

Key Working Relationships

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.

Work Environment

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, standing, walking or sitting, bending and stooping for extended periods of time. Ability to lift up to 35 lbs. Flexible work hours to meet project deadlines.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range is $128,000.00 to $218,000.00 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com .

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