Drug Substance Lead - Large Molecule

Site Name: USA - Pennsylvania - King of Prussia, USA - Maryland - Rockville Posted Date: Feb 9 2023 The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, through a focused strategy execution. MSAT is the keeper of the body of knowledge associated with the formulation, device components, analytical testing, and manufacturing unit operations, creating the instruction set and ensuring manufacturing operations stay aligned with the registered process. The primary objective is to ensure manufacturing processes are capable, compliant, in control, continuously improved and aligned across Sites. MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support, provide process support across the product lifecycle, while implementing new products and new modalities for commercial products and product-related improvement programs within the GSK GSC perimeter. Are you looking for an opportunity to optimize the technical performance of GSK products in the supply chain? If so, this is the role for you. As Drug Substance Lead (Large Molecule), you will manage and provide technical leadership for a product or product family to ensure the product is delivered through manufacturing to the highest level of quality and robustness. You will be the point of contact for all aspects of the product. This role supports the Molecule Technical Steward who has technical accountability for the product. You will shadow the MPD Workstream lead, leading the technology transfer and then taking ownership of the product control strategy on transfer to GSC. You will be responsible for process validation, supporting regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug substance/drug product: Technical Risk Assessment, Product Control Strategy, Continued Process Verification and Process Robustness Assessment. Ensure risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g., CAPAs or governance boards Ensure Quality by Design (QbD) principles are applied, and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialization of new products from R&D, and subsequent transfers to other sites. Assess the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of Technical Risk Assessment and Product Control Strategy. Lead the technology transfer from R&D and then to other manufacturing sites, internally and externally Lead cross functional improvement projects with a clear demonstration of value created Provide technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits. Respond to technical questions during regulatory submission and inspections. Recommend technical readiness to launch, including ensuring technical aspects of Transfer Acceptance Criteria are achieved. Provide leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations. Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate. Provide technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and with R&D. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in scientific discipline. Experienced in technology transfer Experience improving products, processes and troubleshooting, execution of technical activities including validation activities. Experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management. Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and BLA/MAA preparation, Experience in PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, Change and Deviation Management), and knowledge management. Experience supporting due diligence activities. Preferred Qualifications: If you have the following characteristics, it would be a plus: Post Graduate Degree. Understanding of the product development process. Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management. Knowledge of Quality by Design and risk management approaches. Experience Influencing, leading, and driving change within an organization. Proven problem-solving skills and ability to think and work creatively. Record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines. Broad and integrated knowledge and experience that can impact project and workgroup direction. Ability to communicate verbally and in writing. Why GSK? We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together. Find out more: Annual Report 2021
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