Assoc. Dir., Engineering , Combination Products Platform Assembly and Packaging Technical Leadership

Overview

Assoc. Dir., Engineering , Combination Products Platform Assembly and Packaging Technical Leadership

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• Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the MDCP assembly and packaging platform portfolio, including interrogation of the data/science through technical reviews and exploring alternative ways to view and solve problems to achieve results.
• Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
• Collaborate with cross-functional teams to ensure that all platforms (e.g. syringes, auto injectors, kits) meet safety, efficacy, quality, and robust supply standards.
• Develop and maintain strong relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, and Value Chain to facilitate effective technical support and platform stewardship, including above-site support for significant investigations, complaints monitoring and rapid response activities.
• Manage the portfolio of work in the platform, holding the cross-functional team accountable to deliver on priorities.
• Provide strategic leadership and direction for technical support and MDCP packaging & assembly platform stewardship, including managing ongoing changes and tech transfers for components, equipment, and processes. Develop, maintain, and refine technical platform lifecycle management plans, and optimize platform standards.
• Oversee lifecycle changes for MDCP packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards. Ensure thorough engineering, medical device and packaging science is applied to deliverables for new product introductions and tech transfers across the network, including aligning control and validation strategies.

• Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
• Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with ten (10) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
• PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields.

• Subject matter expertise in medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/validation.
• Demonstrated experience in a leadership role; managing cross functional teams supporting medical device and/or combination product assembly and packaging.
• Strong problem-solving and decision-making skills with the ability to interrogate the science, identify true requirements, and detect critical flaws including risk identification, gap analysis and mitigation strategies.
• In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging.
• Strong understanding of risk management principles, including ISO 14971 and other relevant standards.
• Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
• Excellent communication and interpersonal skills,…