Director of Manufacturing & Site Lead

The role

The Director of Manufacturing & Site Lead will establish, commission, and lead manufacturing operations at the Allentown facility. This hands-on role involves taking the facility from construction and operational readiness through validation, licensing, product transfer, and commercial production.

What you will do

• Lead manufacturing readiness activities during facility construction and build-out
• Support equipment installation, commissioning, qualification, and validation
• Establish manufacturing operations for kitting and packaging product lines
• Lead the transfer, installation, qualification, and validation of the Spectrum 1 coating line
• Partner with Quality, Regulatory, Engineering, and Supply Chain to achieve site validation
• Support state drug manufacturing licensing and other regulatory requirements
• Recruit, onboard, train, and develop the site's hourly and supervisory workforce
• Establish site KPIs and daily management systems
• Serve as the senior operational leader for the Allentown facility
• Manage the site's operating budget and manufacturing costs

Required qualifications

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

Nice to have

• Bachelor's degree in Engineering, Operations, Business, Life Sciences, or a related discipline
• Master's degree or MBA
• 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

About the company

Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. The company was formed through the acquisition of a portfolio of trusted products.