Hispanic Alliance for Career Enhancement
Director, Packaging Distribution, Components and Systems Centers of Excellence (
Hispanic Alliance for Career Enhancement, West Point, Pennsylvania, us, 19486
Overview
The Director Packaging Distribution, Components and Systems Center of Excellence (COE) reports to the Executive Director Packaging Technical Operations and is responsible for technical leadership, strategic planning, and portfolio execution of key work supporting the COE for the packaging and device community. This includes logistics and distribution technologies, small molecule bulk and primary packaging components, and packaging master data and systems. 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 ensure an uninterrupted, compliant supply of commercialized products for patients. The Director of Packaging Distribution, Components and Systems COE provides deep packaging and/or combination product technical expertise, strong problem-solving, strategic acumen, and execution capabilities, along with exceptional leadership to shape technical capabilities and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts providing COE support to the enterprise, executing the organization’s priorities and ensuring successful project completion. This includes providing SME guidance for logistics and distribution technologies (e.g., thermal container qualification from frozen to room temperature shipments, distribution (shock and vibration) qualification, and data collection systems for distribution such as temperature monitors), SME guidance for small molecule drug substance and drug product container closure systems (including mold qualification and regulatory compliance), and acting as master data stewards to support enterprise-wide component specification management and documentation systems for the packaging community. COE teams support lifecycle changes, investigations, troubleshooting, and continuous improvement to guarantee robustness and compliance of the product portfolio across internal and external networks. The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, supply chain, commercialization teams across the end-to-end supply chain, and analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on 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 rigour, technical problem solving, and execution excellence across the distribution, component and systems COE 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 and stakeholders to ensure that all solutions (e.g. thermal containers, package designs, new components) meet safety, efficacy, quality, and robust supply standards. Develop and maintain strong relationships with internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, to facilitate effective COE support to the portfolio. This includes above-site support for significant investigations, developing new solutions, establishing guidance and standard work, and maintaining key systems including component specifications. Provide strategic leadership and direction for technical support across Centers of Excellence, including technical guidance to component or process changes, supporting tech transfers and investigations. Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of COE support. Manage the portfolio of work in the platform, holding the team accountable to deliver on priorities on time and right first time. Ensure thorough engineering and packaging science is applied to deliverables. 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 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 twelve (12) 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 Required Skills and Experience
Subject matter expertise in packaging and/or medical device and combination product components, as well as development and qualification of package design and/or distribution/transportation technologies for pharmaceutical products. Demonstrated depth in 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. Demonstrated experience in a leadership role; managing technical teams supporting packaging 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 the ability to determine areas of potential risk, generate gap analyses and mitigation strategies. In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging, including Good Distribution Practices (GDP) as well as thermal and distribution qualification for pharmaceutical products. Strong understanding of risk management principles. 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. Note:
This posting includes standard EEO statements and compliance information. Our company is committed to inclusion and providing accommodations during the application process as needed. Hiring Details
The salary range for this role is $169,700.00 - $267,200.00. The successful candidate will be eligible for annual bonus and long-term incentives, if applicable. We offer a comprehensive benefits package. You can apply at the company careers site. The application deadline is stated on the posting. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will work a hybrid schedule as described in the posting. This model does not apply to field-based, facility-based, or other positions where remote work is not feasible. Travel: 10%. Relocation: Domestic. VISA Sponsorship: No.
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The Director Packaging Distribution, Components and Systems Center of Excellence (COE) reports to the Executive Director Packaging Technical Operations and is responsible for technical leadership, strategic planning, and portfolio execution of key work supporting the COE for the packaging and device community. This includes logistics and distribution technologies, small molecule bulk and primary packaging components, and packaging master data and systems. 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 ensure an uninterrupted, compliant supply of commercialized products for patients. The Director of Packaging Distribution, Components and Systems COE provides deep packaging and/or combination product technical expertise, strong problem-solving, strategic acumen, and execution capabilities, along with exceptional leadership to shape technical capabilities and strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts providing COE support to the enterprise, executing the organization’s priorities and ensuring successful project completion. This includes providing SME guidance for logistics and distribution technologies (e.g., thermal container qualification from frozen to room temperature shipments, distribution (shock and vibration) qualification, and data collection systems for distribution such as temperature monitors), SME guidance for small molecule drug substance and drug product container closure systems (including mold qualification and regulatory compliance), and acting as master data stewards to support enterprise-wide component specification management and documentation systems for the packaging community. COE teams support lifecycle changes, investigations, troubleshooting, and continuous improvement to guarantee robustness and compliance of the product portfolio across internal and external networks. The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, supply chain, commercialization teams across the end-to-end supply chain, and analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost/benefit decisions based on 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 rigour, technical problem solving, and execution excellence across the distribution, component and systems COE 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 and stakeholders to ensure that all solutions (e.g. thermal containers, package designs, new components) meet safety, efficacy, quality, and robust supply standards. Develop and maintain strong relationships with internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, to facilitate effective COE support to the portfolio. This includes above-site support for significant investigations, developing new solutions, establishing guidance and standard work, and maintaining key systems including component specifications. Provide strategic leadership and direction for technical support across Centers of Excellence, including technical guidance to component or process changes, supporting tech transfers and investigations. Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of COE support. Manage the portfolio of work in the platform, holding the team accountable to deliver on priorities on time and right first time. Ensure thorough engineering and packaging science is applied to deliverables. 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 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 twelve (12) 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 Required Skills and Experience
Subject matter expertise in packaging and/or medical device and combination product components, as well as development and qualification of package design and/or distribution/transportation technologies for pharmaceutical products. Demonstrated depth in 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. Demonstrated experience in a leadership role; managing technical teams supporting packaging 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 the ability to determine areas of potential risk, generate gap analyses and mitigation strategies. In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging, including Good Distribution Practices (GDP) as well as thermal and distribution qualification for pharmaceutical products. Strong understanding of risk management principles. 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. Note:
This posting includes standard EEO statements and compliance information. Our company is committed to inclusion and providing accommodations during the application process as needed. Hiring Details
The salary range for this role is $169,700.00 - $267,200.00. The successful candidate will be eligible for annual bonus and long-term incentives, if applicable. We offer a comprehensive benefits package. You can apply at the company careers site. The application deadline is stated on the posting. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will work a hybrid schedule as described in the posting. This model does not apply to field-based, facility-based, or other positions where remote work is not feasible. Travel: 10%. Relocation: Domestic. VISA Sponsorship: No.
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