KNG Technical Inc.
Vice President of Molecular Diagnostics
KNG Technical Inc., Chicago, Illinois, United States, 60290
Department Name:
Manufacturing ManagementLocation:
USASummary:The VP of Molecular Diagnostics is a leadership position responsible for:All aspects of Molecular Diagnostics assay product realization at multiple sites leading to the production of safe, effective, and compliant IVD and RUO products, including the current assay portfolio.Span of control that includes manufacturing, quality control, and design transfer functions and responsibilities.Ensuring quality and production requirements for all associated operations, including facilities, resources, and equipment to fulfill the business plan. Assay manufacturing operations span from oligo/reagents manufacturing to non-automated and sample-to-answer assay products.Financial and operational metric performance, adherence to cGMP requirements, management of direct reports and their staff, and development of strategic plans.Key Responsibilities & Duties:Direct, plan, and perform manufacturing operations and manage associated personnel.Ensure compliance with corporate guidelines and procedures, as well as FDA regulatory requirements and applicable domestic and international standards.Develop and execute plans and resource requirements to ensure production output aligns with the business plan.Implement strategic direction for operations to ensure readiness for new product introductions.Manage product and production changes necessary to ensure product availability, support, and compliance.Plan and implement business process optimization and lean initiatives to eliminate waste and enhance control, responsiveness, and flexibility.Pursue efficiency improvements and cost reduction efforts consistent with corporate goals.Oversee the production process and evaluate adequacy for proper regulatory reporting and/or product recalls.Lead planning and delivery of global business process integration, improvement, and harmonization initiatives.Establish and drive execution of annual performance commitments aligned with Global Manufacturing and company objectives.Manage annual departmental capital, headcount, and expense budgeting requirements.Develop business system strategies and implementation.Ensure effective prioritization, investigation, and resolution of findings impacting the Manufacturing operation identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.Collect, analyze, and present operational quality and performance data.Engage with cross-functional stakeholders and key business partners across the company to effectively support operations.Other duties as assigned.Education and Experience:Minimum Master’s degree with more than 10 years of related experience and/or training, or equivalent combination of education and experience.At least 10 years of experience in manufacturing and quality in the diagnostics or medical industries.Experience in an FDA regulated industry and/or an ISO certified organization.Training, Skills and Certifications/Licenses:Ability to work independently and with minimal supervision.Highly organized with proven time management and prioritization skills.Ability to handle the pressure of meeting tight deadlines.Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.Ability to effectively present information to top management, public groups, and/or boards of directors.Work Conditions:Work location: USTravel: 30% domestic, 10% internationalWork is typically performed in an office environment in an industrial manufacturing setting with chemical, biological, laser, and noise hazards.Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting of at least 10 lbs. Additional physical requirements include lifting up to 50 lbs.
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Manufacturing ManagementLocation:
USASummary:The VP of Molecular Diagnostics is a leadership position responsible for:All aspects of Molecular Diagnostics assay product realization at multiple sites leading to the production of safe, effective, and compliant IVD and RUO products, including the current assay portfolio.Span of control that includes manufacturing, quality control, and design transfer functions and responsibilities.Ensuring quality and production requirements for all associated operations, including facilities, resources, and equipment to fulfill the business plan. Assay manufacturing operations span from oligo/reagents manufacturing to non-automated and sample-to-answer assay products.Financial and operational metric performance, adherence to cGMP requirements, management of direct reports and their staff, and development of strategic plans.Key Responsibilities & Duties:Direct, plan, and perform manufacturing operations and manage associated personnel.Ensure compliance with corporate guidelines and procedures, as well as FDA regulatory requirements and applicable domestic and international standards.Develop and execute plans and resource requirements to ensure production output aligns with the business plan.Implement strategic direction for operations to ensure readiness for new product introductions.Manage product and production changes necessary to ensure product availability, support, and compliance.Plan and implement business process optimization and lean initiatives to eliminate waste and enhance control, responsiveness, and flexibility.Pursue efficiency improvements and cost reduction efforts consistent with corporate goals.Oversee the production process and evaluate adequacy for proper regulatory reporting and/or product recalls.Lead planning and delivery of global business process integration, improvement, and harmonization initiatives.Establish and drive execution of annual performance commitments aligned with Global Manufacturing and company objectives.Manage annual departmental capital, headcount, and expense budgeting requirements.Develop business system strategies and implementation.Ensure effective prioritization, investigation, and resolution of findings impacting the Manufacturing operation identified through audits, non-conformances, corrective/preventive actions, or customer complaint escalation.Collect, analyze, and present operational quality and performance data.Engage with cross-functional stakeholders and key business partners across the company to effectively support operations.Other duties as assigned.Education and Experience:Minimum Master’s degree with more than 10 years of related experience and/or training, or equivalent combination of education and experience.At least 10 years of experience in manufacturing and quality in the diagnostics or medical industries.Experience in an FDA regulated industry and/or an ISO certified organization.Training, Skills and Certifications/Licenses:Ability to work independently and with minimal supervision.Highly organized with proven time management and prioritization skills.Ability to handle the pressure of meeting tight deadlines.Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.Ability to effectively present information to top management, public groups, and/or boards of directors.Work Conditions:Work location: USTravel: 30% domestic, 10% internationalWork is typically performed in an office environment in an industrial manufacturing setting with chemical, biological, laser, and noise hazards.Physical Demands: All positions require standing, stooping, bending, climbing, sitting, kneeling, and lifting of at least 10 lbs. Additional physical requirements include lifting up to 50 lbs.
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