Site Name: Durham Blackwell Street Posted Date: Jan 7 2025 Are you energized by a highly technical packaging design role that allows you to enhance your leadership skills in a state-of-the-art manufacturing environment? If so, this Technical Packaging Lead, role could be an exciting opportunity to explore. As a Technical Packaging Lead, you will be responsible for the development of primary packaging standards to be applied globally, development of all packaging for New Product Introductions (NPI’s) produced in External Supply Sites, and the qualification of temperature control shipments in support of NPI’s and US market. The scope of NPI activities is limited to the Medicines Portfolio. The Technical Packaging Lead will be primarily responsible for Primary Packaging standards development in support of the Medicines portfolio. In addition, this role will support the qualification of temperature-controlled packaging used to support drug substance shipments for biopharma products in the Medicines supply chain. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Collaborate with R&D, Procurement, Regulatory, Quality, and supply chain to identify Primary packaging standard platforms that need to be developed. Lead or participate on teams to develop specific primary packaging solutions that meet the platform requirements taking into account: Materials of construction Compliance with appropriate regulations related to Protection, Safety, Compatibility, and Performance Stability Extractables and Leachable Design for Manufacture Once a primary packaging solution is developed support the qualification of the commercial supply including: Supplier selection Component Qualification of the Suppliers process Line trial and qualification activities in final packaging site Appropriate qualification testing on finished package (distribution testing, child resistance, USP, etc.) Document the qualified component as a standard in VQD providing supporting documents from the qualification to support sites in adopting and implementing the standard primary packaging format. Provide ongoing technical support to primary packaging platforms throughout the lifecycle including material changes, supplier site or process changes, quality issues etc. Provide Tier II support to sites regarding issues with non-platform primary packaging with complex issues or changes. Support development of Business Cases to support effective decision making. Responsible to support execution activities associated with Design Qualification (DQ), Operational Qualification (OQ), and Performance Qualification (PQ) of temperature-controlled solutions for drug substance. Including protocol development, protocol execution and reporting results. The Scope of this role will include Drug product shipments; Leg A (site to site) and Leg B (site to Market). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in engineering or related science degree 10+ years in pharmaceutical packaging with experience in primary packaging development and operations. Experience in the pharmaceutical packaging field related to packaging equipment, pack development and packaging operational activities across multiple dose forms. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master’s degree in engineering Proven track record of innovation delivery Strong project and team management experience Ability to handle multiple/complex issues simultaneously Proven track record for managing a virtual matrix team within a complex, multi-disciplinary technical organization, and working across organizational, territorial, and cultural boundaries. Knowledge/Expertise of packaging materials, components, suppliers, equipment, legislation, and technologies with the Deep knowledge of primary packaging including materials, design, and process knowledge of supplier's process as well as packaging production operations involving primary packaging. Knowledge of regulatory requirements related to primary packaging (USP, EP, CFR, etc.) Demonstrated ability to manage and control multiple tasks simultaneously. Understanding of the complexities of multi-site manufacture for GSK Products, internal and within External Supply Superior listening skills, analytical ability to diagnose problems, resolve conflict, and develop practical solutions. Excellent communication skills, both interpersonal and presentation; able to interact with and influence all levels of individuals across a variety of organizations (without a direct reporting relationship). Lead a cross functional team to determine key tasks and plans which ensure delivery is aligned with business goals Provide a professional service that understands urgency, rapid response and follow-up. Must be able to work in a matrix environment both within the Supply Chain and across R&D, and Commercial where applicable. Build confidence across all stakeholders in own ability to identify, evaluate and make change happen. Understanding different perspectives and satisfying the needs and expectations of all stakeholders. Build peer networks and manage relationships with our supplier base and be able to diagnosis and resolve problems that occur in the packaging operations at sites Develop strong relationships with Procurement groups and suppliers of packaging components #LI-GSK #Featuredmanufacturingjobs Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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