• 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.

• 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.

Job Scope

The Director, Manufacturing will be responsible for:

Ensuring resources, equipment and facilities are in place to deliver production requirements for the business plan.

Ensuring adherence to all requirements of cGMP, adequate availability of product, and the effectiveness and efficiency of the production process in concert with company goals and objectives.

Daily intra-organization interaction as well as frequent inter-department interfaces across the organization with Quality Assurance, Tech Ops, Engineering, Supply Chain, Research and Development, Marketing, Product Management, Project Management, Document Control, Cost Accounting, and Executive Management across sites.

Key Duties and Responsibilities

• Responsible for direction, planning, development, and performance of manufacturing operation and associated personnel.
• Effectively hire, train, develop, and evaluate staff in alignment with business needs. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with Human Resources as appropriate.
• Develop and execute plans and resource requirements to ensure fulfillment of required production per business plan and design transfer for new and changed product development, validation, and market release phases.
• Direct strategy for development and implementation of new initiatives, policies, and programs related to Operations. Provide oversight of the production process and evaluate adequacy for proper regulatory reporting and/or product recalls.
• Implement efficiency improvements and cost reduction efforts consistent with corporate goals.
• Ensure compliance to all applicable FDA, ISO, Luminex Quality System, and safety requirements.
• Resolve findings impacting the Manufacturing Operation identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
• Develop and manage annual departmental capital, headcount, and expense budgeting requirements. Ensure accurate costing through effective management of make item BOM's, resource routing, lot size standards, and variances; anticipate forward looking cost change impacts relative to operational plans.
• Plan and implement business process optimization and lean initiatives to eliminate waste and enhance control, responsiveness, and flexibility.
• Engage and work with cross-functional stakeholders and key business partners across Luminex to effectively support the operation of the department. Collect, analyze, and present data to support recommendations to stakeholders and key business partners.
• Other duties as assigned.

Education, Experience, and Qualifications

• Bachelor's Degree in Biomedical, Chemical, Mechanical, or Industrial Engineering related disciplines.
• 10+ Years Manufacturing operations leadership experience
• 3+ Years Experience in FDA regulated industry and/or ISO certified organization.
• 5+ Years Direct management of teams in biotech or medical device manufacturing
• 3+ Years Prior experience in molecular diagnostics

What we offer

Receive a competitive salary; $150,000 - $190,000 annual salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.