Essential Duties & Responsibilities:- Recruit, train, and oversee staff while managing daily operations, including manufacturing scheduling, procurement, receiving, shipping, and equipment utilization.
- Ensure all processes, documentation, and batch records meet ISO 13485 and FDA requirements, while supporting audit readiness for internal and external reviews and leading CAPA (Corrective and Preventive Action) activities.
- Manage and monitor KPIs: OTIF, throughput, customer satisfaction, supplier survey and present findings to leadership.
- Develop methods to analyze performance in supply chain and customer service areas and provide actionable solutions.
- Collaborate with the finance team to review and refine inventory accuracy and product standard costs, ensuring that cost of goods and profit margins align with company objectives.
- Oversee a comprehensive equipment maintenance program, including calibration, preventive maintenance (PM), and ensuring the availability of required spare parts.
- Develop and manage Operational KPIs for the business.
- Develop and update SOPs to cGMP
- Provide accurate and timely reports for related business units (customers, management, finance, RAQA)
Education & Requirements:- Bachelor's degree from a four-year college or university required (Business, Supply Chain/Logistics, or Sciences).
- Minimum of 4-5 years of managerial or supervisory experience required.
- Strongly preferred: knowledge of ISO 13485, cGMP, and FDA regulations within the IVD industry, as well as experience in reagent/chemical manufacturing (or a similar industry) and supply chain/logistics.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
We offer an extensive benefit and compensation package that includes medical, dental, vision, 401k, PTO, life and disability insurance, as well as a comprehensive leave program. Pay anticipated for this position in New Jersey is from $93,000-$120,000, depending on a number of factors. In the ordinary course of business, compensation and benefits programs may change based upon the Company's needs.
