Director of Manufacturing & Site Lead

About Spectrum Vascular

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset.

The Director of Manufacturing & Site Lead is responsible for establishing, commissioning, and leading manufacturing operations at Spectrum Vascular's Allentown, Pennsylvania facility. This

is a hands-on site leadership role with responsibility for taking the facility from construction and operational readiness through validation, licensing, product transfer, and commercial production.

During the initial phase of the role, the Director will lead the operational start-up of the approximately 74,000-square-foot facility, including two cleanrooms, a QC laboratory, warehouse operations, and supporting infrastructure. Key priorities include establishing kitting and packaging operations and transferring and validating Spectrum's coating manufacturing process from Cook Medical while maintaining timing necessary to support continuity of product supply. The Director will build and lead the site organization, including approximately 40 hourly and supervisory employees anticipated by mid-2027, and will establish the operating systems, processes, culture, and performance standards necessary to support a highly regulated manufacturing environment. Following site start-up, the Director will have ongoing accountability for manufacturing operations, safety, cost, delivery, productivity, facilities, and overall site performance.

Initial Site Start-Up and Operational Readiness

Role Responsibilities

During approximately the first 12 months, the Director will have significant responsibility for:

• Leading manufacturing readiness activities during facility construction and build-out.
• Supporting equipment installation, commissioning, qualification, and validation.
• Establishing manufacturing operations for kitting and packaging product lines.
• Leading the transfer, installation, qualification, and validation of the Spectrum 1 coating line currently operated by Cook Medical.
• Driving the Spectrum 1 transfer and validation schedule to support production readiness before bridge inventory is exhausted.
• Partnering with Quality, Regulatory, Engineering, Supply Chain, and external resources to achieve site validation and regulatory readiness.
• Supporting state drug manufacturing licensing and other applicable regulatory requirements.
• Establishing production workflows, staffing models, training programs, standard work, and manufacturing controls.
• Recruiting, onboarding, training, and developing the site''s hourly and supervisory workforce.
• Establishing site KPIs and daily management systems across safety, quality, delivery, cost, and productivity.
• Preparing the facility and manufacturing organization for regulatory and customer inspections.

Responsibilities & Duties

Site Leadership: Serve as the senior operational leader for the Allentown facility, with responsibility for employees, manufacturing operations, facilities, company property, business

continuity, and relationships with applicable local authorities.

Team Leadership: Recruit, train, lead, coach, and evaluate manufacturing employees and supervisors. Build an accountable, high-performance culture focused on safety, quality,

teamwork, continuous improvement, and employee development.

Manufacturing Operations: Establish and manage manufacturing processes to ensure products are produced safely, compliantly, efficiently, on time, and within budget. Develop and monitor

KPIs and operating metrics to drive performance.

Manufacturing Strategy: Develop and execute manufacturing strategies aligned with Spectrum''s business objectives, with particular focus on safety, quality, delivery, cost,

productivity, capacity, and scalability.

Employee Safety and EHS: Provide site leadership for employee safety and environmental compliance. Establish appropriate controls and operating practices associated with chemical and

coating processes, including solvent handling, drug powders, hazardous materials, hazardous waste, air permitting, ergonomics, and injury prevention.

Quality and Regulatory Partnership: Partner closely with Quality and Regulatory Affairs to maintain compliance with applicable FDA requirements, the FDA Quality Management System

Regulation (QMSR), ISO 13485, combination-product requirements including 21 CFR Part 4, and applicable cleanroom and environmental-monitoring requirements.

Quality retains responsibility for independent quality oversight, product release, and QC laboratory activities. The Site Lead is accountable for manufacturing execution, production

documentation, employee training, investigation and CAPA follow-through, manufacturing corrective actions, and maintaining a state of inspection readiness.

Inspection Readiness: Maintain manufacturing operations in a continuous state of readiness for inspections and audits by FDA, BSI, applicable state regulatory authorities, customers, and other

regulatory bodies.

Budget and Cost Management: Develop and manage the site''s operating budget, monitor manufacturing costs, manage labor and operating expenses, and identify opportunities to

improve productivity and reduce cost without compromising safety, quality, or compliance.

Continuous Improvement: Establish a continuous-improvement culture in which employees and leaders identify and execute improvements in safety, quality, delivery, cost, workflow,

capacity, and manufacturing performance.

Cross-Functional Collaboration: Work closely with Quality, Regulatory, Engineering, Supply Chain, Procurement, Finance, R&D, and other functions to support site readiness, product

transfers, production planning, new-product introduction, and business objectives.

Technology and Manufacturing Systems: Lead implementation and optimization of manufacturing technologies, equipment, systems, and processes that improve operational

performance, scalability, traceability, and cost.

Facilities and Business Continuity: Ensure manufacturing equipment, utilities, facilities, and supporting infrastructure are appropriately maintained and capable of supporting validated

operations. Develop business continuity and contingency plans for critical equipment, utilities, processes, and supply risks.

Other Responsibilities: Perform other duties as required to support the successful establishment and operation of the Allentown manufacturing site.

Role Qualifications & Experience

• Minimum of 10 years of progressively responsible manufacturing operations experience in an FDA-regulated medical device, pharmaceutical, combination-product, or similarly

regulated manufacturing environment.

• Minimum of 5 years of leadership responsibility for a manufacturing site, significant manufacturing operation, or multiple production lines.
• Demonstrated experience leading a new manufacturing site start-up, major facility expansion, or product/process transfer through commissioning, qualification, validation,

and commercial production.

• Experience operating within ISO-classified cleanroom environments, preferably ISO 7 and/or ISO 8.
• Experience with sterile or controlled-environment packaging operations.
• Experience with chemical, coating, pharmaceutical, or similar manufacturing processes involving controlled handling of solvents, chemicals, or drug materials.
• Demonstrated experience building, staffing, training, and developing an hourly manufacturing workforce.
• Strong working knowledge of FDA-regulated manufacturing requirements, QMSR, ISO 13485, cGMP principles, and applicable validation requirements.
• Demonstrated ability to establish manufacturing systems, standard work, performance metrics, and operating disciplines in a start-up or rapidly evolving environment.
• Proven record of implementing operational and process improvements.
• Strong understanding of production planning, capacity management, labor planning, and manufacturing economics.
• Experience managing operating budgets, production costs, and cost-reduction initiatives.
• Strong EHS orientation and experience managing manufacturing safety and environmental risks.
• Exceptional leadership, problem-solving, analytical, decision-making, and projectmanagement capabilities.
• Ability to operate strategically while remaining highly hands-on and execution focused.
• Ability to manage multiple priorities in a fast-paced, changing environment and lead effectively through ambiguity.
• Excellent communication and cross-functional leadership skills.

Education

• Bachelor''s degree in Engineering, Operations, Business, Life Sciences, or a related discipline preferred.
• Substantial directly relevant manufacturing leadership experience may be considered in lieu of a degree.
• Master''s degree or MBA preferred but not required.

Preferred Qualifications

• Medical-device or combination-product manufacturing experience.
• Experience with drug-device combination products and 21 CFR Part 4.
• Experience transferring manufacturing processes between contract manufacturers and internal manufacturing facilities.
• Experience with coating or chemical processing operations.
• Lean Manufacturing, Six Sigma, or comparable continuous-improvement certification or experience.
• Experience supporting FDA, notified body, state regulatory, or customer inspections

Work Environment:

On site in our Lehigh Valley manufacturing facility, with occasional office work. Some travel may be required to visit suppliers or customers, especially in the first 6-9 months.

Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion,

national origin, age, veteran status, or any other protected status under the law.