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

Overview

Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical Leadership at Merck. Reporting into the Director Packaging Platform Technical Leadership, the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and Assembly Technical Leadership will be responsible and accountable for technical leadership, strategic planning and portfolio execution of key packaging and assembly platforms, with a focus on combination drug products such as prefilled syringes and autoinjectors.

Responsibilities

• 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 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. This includes 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 the components, equipment, and processes. Develop, maintain, and refine technical platform lifecycle management plans, setting and managing and optimizing 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 inclusive of aligning the control and validation strategies.

Minimum Education Requirements And Experience

Required Skills And Experience

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Current Contingent Workers apply HERE

US And Puerto Rico Residents Only

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Additional Details

Hybrid work model in the U.S. applies; salary range $126,500.00 - $199,100.00; bonus and long-term incentive eligibility; relocation domestic; travel up to 10%; job is full-time; no visa sponsorship.

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