Director, Operations

How You’ll Contribute:

• Lead the Operations and Engineering activities associated with operationalizing ELutia’s manufacturing facility and production processes, including facility and equipment qualification, process validation, process optimization, and ongoing operation/maintenance.
• Launch manufacturing processes for a medical device consisting of a biological material, and a combination device consisting of a biological material and two antibiotic drugs. Lead the tech transfer of the production process from an external contract manufacturer, author key operational documents including specifications, procedures, work instructions, review and approve documents in a timely manner, etc.
• Provide leadership in Design Control, leading development of the Design History File (DHF), Device Master Record (DMR), Failure Modes and Effects Analysis (FMEA), and Verification and Validation (V&V).
• Manage the operationalization of the facility and production lines to meet project timelines. This is a fast-paced environment and this leader will be responsible for balancing multiple priorities concurrently.
• Hire, manage, mentor and develop the Operations team to support professional growth for employees. Lead the development of a team culture that aligns with Elutia’s CRU values.
• Collaborate closely with Quality, R&D, and Regulatory teams to allow efficient knowledge transfer, ensure all Design Control requirements are met, and comply with all regulatory requirements
• Manage day-to-day Operations, including materials management, manufacturing, labeling and packaging, shipping and receiving, equipment calibration and maintenance, and vendor management to sustain appropriate inventory levels.    
• Lead continuous operational improvement activities, including identifying areas for optimization, prioritizing necessary projects, revising documentation to reflect improvements, training the team on new procedures, and monitoring impact of improvement projects.
• Responsible for the identification of issues and initiation of actions to prevent the occurrence of any nonconformity relating to products, processes, and the quality system as applicable to the responsibilities outlined with this job description.
• Responsible for collaborating with Quality to communicate with FDA, notified bodies, and regulators during on-site audits and inspections.

What You Bring: 

• BS in a manufacturing engineering discipline required; MS preferred.  
• Minimum of 15 years’ experience as an operations or engineering professional in the medical device industry, having actively participated and/or managed an Operations function.
• Direct FDA inspection experience required.
• Experience complying with the following quality framework is required: Quality System (QSR) Regulation (21 CFR part 820) for Medical Devices,and required provisions from drug current Good Manufacturing Practice (21 CFR Part 211) in accordance with 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach) for combination drug-device products.
• Experience transferring a manufacturing process from an external contract manufacturing and an internal R&D team with tight project timelines is required.
• Experience with launching a medical device manufacturing facility and production processes is required.
• Able to anticipate issues, and proactively resolve them.
• Able to work in a fast-paced environment, balancing multiple priorities, and creative problem solving is critical for this role.
• Possesses excellent mentoring, leadership, time management, and project management skills.
• Specialized Skills, Knowledge:
• Familiar with FDA 21 CFR part 820, 21 CFR 4.4(b)(2) and ISO 13485 requirements.