Our client, an emerging leader in the field of in vitro diagnostics, has an immediate opening for a Reagent Manufacturing Manager. This role will be responsible for oversight and leadership of all Reagent Manufacturing activities in compliance with the FDA Quality System Regulation (QSR) and ISO 13485.

Responsibilities:

• Establish and oversee end-to-end reagent manufacturing processes ensuring product quality, volume, and financial goals are achieved
• Attract, manage, and develop manufacturing team members, foster a positive work environment and a culture of continuous improvement and accountability
• Identify, plan, and implement LEAN initiatives needed to increase product manufacturing capabilities
• Develop and maintain a solid hands-on understanding of manufacturing processes by spending time in manufacturing clean rooms and working side-by-side with production team members, as needed
• Partner with R&D, Engineering, Field Service, Marketing/Sales, Finance, and other departments to ensure that products, processes, plans, and requirements are translated into manufacturing operational plans
• Partner with Quality, Supply Chain, Logistics, Planning, and other operational team members to ensure all suppliers are held accountable for performance and continuous improvement - including product quality, lead time reduction, delivery, flexibility, inventory reduction, and cost reduction
• Proactively identify risks and propose action plans for resolution
• Maintain validated facilities, equipment, and processes related to reagent manufacturing; ensure environmental, health, and safety procedures are followed at all times
• Other responsibilities as required

Requirements:

• Bachelor’s Degree in related scientific or engineering discipline required
• Minimum of 7+ years of manufacturing experience in an FDA regulated environment required, ideally within medical device or diagnostics industry
• Must have hands-on experience with aseptic production methods
• Must have experience with the technical transfer and scale-up from product development to manufacturing operations
• Must have experience in attracting, building, developing, managing, and performing hands-on training for strong, high performing manufacturing teams with a quality mindset
• Must have thorough knowledge of Good Manufacturing Practice (GMP) and lean manufacturing principles
• Familiarity with Material Requirements Planning (MRP) and ERP systems with multi-level Bills of Material required
• Experience using Oracle strongly preferred
• Must demonstrate sense of ownership and accountability
• Work with a results-oriented approach and a sense of urgency, use sound judgment, and have strong attention to detail
• Must be flexible and able to effectively manage multiple organizational priorities
• Ability to communicate effectively and approach tasks with a can-do and positive attitude