Merck
Director, Engineering Assembly and Packaging Platform Technical Leadership
Merck, West Point, Pennsylvania, us, 19486
Dir, Engineering - Director, Assembly and Packaging Platform Technical Leadership
Reporting into the Executive Director Packaging Technical Operations, the Director Packaging and Assembly Platform 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. The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Director of Packaging and Assembly Platform Technical Leadership is integral to this mission. The successful candidate will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape the technical capabilities and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key packaging and assembly platforms. They will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes the development and execution of robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external networks. The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, packaging & device development and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on the analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement. Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the 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 and ensure that all platforms (e.g. syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies. 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. Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Manage the total platform portfolio of work, holding the team accountable to deliver on priorities Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers for the components, equipment, and processes. Deliver on the development, maintenance, and refinement of technical platform lifecycle management plans, setting and managing and optimizing platform standards. Provide technical guidance to lifecycle changes for 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: Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience 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 twelve (12) years relevant experience 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 pharmaceutical packaging, combination product assembly and packaging, or related technical fields Required Skills and Experience: 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 technical teams supporting packaging as well as combination product assembly & packaging. Strong problem-solving and decision-making skills with an ability to determine interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate 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, with the ability to effectively engage with internal and external stakeholders.
Reporting into the Executive Director Packaging Technical Operations, the Director Packaging and Assembly Platform 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. The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Director of Packaging and Assembly Platform Technical Leadership is integral to this mission. The successful candidate will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape the technical capabilities and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible for technical leadership of key packaging and assembly platforms. They will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes the development and execution of robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external networks. The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, packaging & device development and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on the analysis of inputs, outcomes, risks, and company-wide prioritization. Essential Responsibilities: Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement. Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the 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 and ensure that all platforms (e.g. syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies. 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. Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities. Manage the total platform portfolio of work, holding the team accountable to deliver on priorities Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers for the components, equipment, and processes. Deliver on the development, maintenance, and refinement of technical platform lifecycle management plans, setting and managing and optimizing platform standards. Provide technical guidance to lifecycle changes for 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: Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience 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 twelve (12) years relevant experience 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 pharmaceutical packaging, combination product assembly and packaging, or related technical fields Required Skills and Experience: 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 technical teams supporting packaging as well as combination product assembly & packaging. Strong problem-solving and decision-making skills with an ability to determine interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate 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, with the ability to effectively engage with internal and external stakeholders.