Senior Manager, Technical Operations

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  Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
  

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  Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
  

The Senior Manager, Technical Operations is responsible for leading a team that owns Design Transfer ensuring Design for Manufacturability, on-market support, resolving technical issues with existing products, process improvements, process development and validations. This position is a technical leadership position is responsible for hiring, managing, developing, and mentoring a group of scientists, engineers and associates to create a high performing team.

Job Scope:

• Responsible for technical and scientific support and expertise to manufacturing operations with regards to products and processes. Assist the manufacturing operation in problem solving with regards to products and associated systems, design, processes, equipment and scale up. Develops and recommends new process formulas and technologies to achieve cost effectiveness and improved product quality. Provides support to design teams and new product development teams as operations representative to ensure manufacturability of products, robust product/process developments, technology transfer and manufacturing scale up and stability.
• Manages projects in conjunction with cross functional teams responsible for initiating, planning, executing, monitoring and closing of projects associated with implementation of Operation's wide initiatives. Will also providing technical support to external manufacturers, customers and key partners as needed.
• The position will also direct and provide project management support for key strategic projects working with both internal and external resources to manage the projects to meet all key milestones. This position will also be involved in process development, optimization and process validation activities. Additionally, the position will monitor and control labor and capital expenditures, assist in developing budgets, analyze technical capabilities in manufacturing.
• During Investigations into field complaints and/or medical recalls supports all applicable regulations including but not limited to FDA, ISO, and CMD/CAS requirements.

Key Duties and Responsibilities:

• Help to ensure compliance to ISO 9001/EN 46001 and ISO 13485 requirements.
• Serve as key technical guide for the design and implementation of all current and new products, processes, procedures and specifications.
• Establish metrics and monitors trends of manufacturing process/product performance to ensure adherence to quality requirements and specifications. Partners with Quality and R&D to address / resolve any issues.
• Provides technical support to operations in the resolution of issues and initiation of new projects and initiatives.
• Assist with the initiation of new projects. Interface with key cross functional team members to draft project charters and other related activities associated with Operations and External Partners
• Develops and update project schedules that provide the detailed list of tasks and timing for each phase of the project
• Proactively monitors and records project risks, communicating potential problems
• Assist quality and regulatory departments to prepare, conduct, host and respond to internal and external quality audits.
• Identifies improvement opportunities in the areas of quality, delivery and cost, and leads projects to implement. Advise management of opportunities and risks and develops contingency plans accordingly.
• Evaluate the technical capability of outsource providers and make recommendations of proper fit
• Analyze and interpret data, identify problems and make decisions involving the insourcing or outsourcing of new or existing products and processes.
• Actively work with government agencies on grant projects ensuring accurate project costing and reporting
• Oversee technical relationship with outside partner companies related to Operations initiatives
• Develop and revise specifications and procedures, protocols, studies and other documents as needed to ensure adequate compliance with ISO and GSR requirements.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees.
• Develop and recommend new process formulas and technologies to achieve cost effectiveness and improve product quality.
• Identify and resolve technical problems that may occur.
• Coordinate with the Research and Development, Manufacturing and Quality departments on new product scale-up, process, optimization, technology transfer, and process validation activities.
• Provide consultation with the technical staff and actively inter phases with the Research and Development department.
• Interface with process and equipment automation technology.
• Establishes robust development plans for his/her direct reports and strives to create a culture that is customer centric, strives to attain excellence and is fully engaged.
• Perform other duties as assigned.

Education, Experience, and Qualifications:

• Ph.D. Biomedical related discipline required or
• Master's Degree Biomedical related discipline required or
• Bachelor's Degree Biomedical related discipline required
• 5+ Years Technical Operations, Design Transfer, On-Market Support, Product Development or a combination of experience. required
• 5+ Years Experience in a regulated environment with GMP in IVD, Medical Device, Pharmaceutical or similar field. required

Travel Requirements

• 10% Infrequent travel to other Luminex / DiaSorin sites on as needed basis.

What we offer/Salary Range

The salary range for this position is $92,891-$165,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.