Site Name: USA - Pennsylvania - Marietta Posted Date: Dec 19 2024 Are looking for a process and validation leadership role that allows you to leverage your technical expertise to drive quality assurance and compliance in a highly technical manufacturing environment? If so, this MSAT Team Lead role could be an exciting opportunity to explore. As an MSAT Team Lead, you will be responsible for leading a team of Process and Validation Specialists/SME’s to manage and deliver the product and project portfolio, including new product introduction and complex changes to existing products, processes and equipment technologies, to meet business demands. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Develop, motivate, focus, care and lead a highly competent team of Process and Validation Specialists/SME’s to deliver projects, discharge risks, implement complex changes and to maintain standards and knowledge management systems for the site. Feeding into the sites Strategic Workforce Planning, through strong succession planning & performance management. To operate in line with GSKs leadership expectations & promote correct behaviors & ways of working to their team & other employees. Use Workday and the supporting 70:20:10 framework to agree development plans for team members. Partner with team members to support development plans to increase and sustain capability within the MSAT team (ensure a competent skill base, technical mastery and strong succession plans). Recruit staff as required in order to deliver projects per timelines. Adhering to the performance management system, holding regular structured performance meetings with all employees in their reporting line, to review development items, recognize success & offer support where required. It will be expected to manage underperformance in a reasonable time frame in line with the GSK performance management policy in a fair & concise way, with an ultimate aim to improve their overall performance. Align themselves & their teams to site priorities, business objectives through effective team leadership & stakeholder management. Maintain individual and staff compliance with all related policies and procedures (including GMP; Environmental, Health & Safety; and QMS), ensuring that all work is performed and documented to a standard that is acceptable to both internal and external reviewers. Industrialize technical transfer of commercial products within Global Supply Chain and other third-party sites as applicable. Key focus areas are risk management, technical due diligence and embedding quality and MSAT capabilities to ensure robust, cost-effective manufacturing processes. Acquire, maintain and manage product and process knowledge throughout the product lifecycle. Acquire, maintain and manage MSAT standards throughout the product lifecycle and ensure they are adhered to. Ensure appropriate systems to track, trend and analyze product and process data are in place in use and applied to monitor product/process performance and drive improvement. Approve and resource MSAT aspects of planned changes for new and commercial products through effective risk management processes and MSAT leadership for complex issues (e.g. investigations). Responsible for providing technical leadership into complex product performance investigations & lead the introduction of highly capable new process technologies & improvement of process capability of existing unit processes. Ensure day to day technical issues are resolved urgently to minimize impact on project(s)/product performance or reject/waste levels. Actively facilitate the improvement of product and process capability across the supply chain, in order to drive improved quality performance, yield, reduction of waste due to the cost of poor quality and optimized cost of goods. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Minimum 10 years’ experience with BS in vaccine pharmaceutical process experience, preferably a multinational one. OR Minimum 5 years’ experience with PhD in vaccine pharmaceutical process experience, preferably a multinational one. Minimum 5 years' demonstrated experience in the Vaccine Pharmaceutical industry in leading the technical aspects of the Product Lifecycle including Scale Up, Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, Process/Cleaning validation, Contamination Control and change control. Preferred Qualifications: If you have the following characteristics, it would be a plus: In-depth knowledge and understanding of vaccine’s raw materials, single use system, filtration, homogeneity, complexation, buffer preparation, formulation, aseptic filling, automated visual inspection and testing. Experience with investigational techniques, tools for process investigations and trouble shootings. Ability to lead, motivate, focus, care and develop others Ability to translate site strategy into team goals and objectives, plan and allocate resources, negotiate support and manage conflicting priorities Track record of improving products, processes and troubleshooting with data and results driven mindset Working knowledge of vaccine manufacturing and the associated materials, components, unit operations, critical parameters and controls Working knowledge of technical transfer, scale-up, process development and validation Knowledge of Product Lifecycle Management, data trending and associated tools (e.g. Risk Assessments, Product Control Strategy, Design of Experiments, product/process capability assessment) Strong analytical and problem-solving skills and ability to generate, use and interpret data to drive decision-making at both tactical and strategic level Excellent verbal and written communication skills, including the ability to author technical reports and review and approve reports written by others Must be flexible, adaptable, and a strong team player Strong experience with major technical projects Strong negotiating and influencing skills and ability to resolve conflict Understanding of manufacturing operations and ways of working Working knowledge of operational excellence methods and tools (e.g. FMEA, Root Cause Analysis, GPS) Working knowledge of the required business systems and tools (e.g. MERP) Good knowledge of internal and external EHS, Quality, Regulatory and GMP requirements #LI-GSK #GSKMarietta #MariettaGSC 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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