Overview Join to apply for the MSAT Product Owner Associate Director role at GSK . We are seeking a leader to join the Manufacturing Science and Technology (MSAT) organization in Upper Merion. This is a site-based role providing technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team delivers continuous improvements to the existing supply chains, supports technology transfers, and implements process-related improvement programs across the product lifecycle with global MSAT collaboration. The MSAT Product Owner Associate Director will lead a team of product owners to support the portfolio of clinical and commercial programs for Upper Merion. Product Owners are the single point of accountability for technology transfer, product lifecycle, CMC strategy, and technical execution for the biopharmaceutical assets manufactured at Upper Merion. The individual will support the team in managing new product introduction, QbD, control strategy, CPV development and maintenance, CMC dossier authoring and health authority questions, and technical product strategy and process efficiency/continuous improvements. The role requires driving continuous improvement in these areas, aligning with platform standards and integrating digital solutions. It will involve cross-functional collaboration with stakeholders in UM Biopharm and globally across MSAT, R&D, regulatory and quality groups. Why this role matters: on-site engagement with teams and processes to make a tangible impact and progress your career. Responsibilities Serve as the Upper Merion lead for a team of site product owners for clinical and commercial programs Drive right-first-time delivery for new product introduction and commercial lifecycle management, including CMC regulatory file authoring and health authority responses Support the delivery of the technical documentation package to support product validation, including validation/verification plans, technical reports/protocols, regulatory filings, and PAI readiness documentation Lead the CPV strategy for the site, ensuring CPV and PPR programs align with regulatory expectations and provide value to the business Drive innovation, digital tool implementation, and continuous improvement for PLM approaches, leveraging CoPs and industry forums to stay current on regulatory guidance and industry trends Develop and provide training for MSAT team members on PLM/PV concepts Qualifications Basic Qualifications: Bachelors with a minimum of 8 years OR a Masters (MS) degree with a minimum of 5 years OR PhD with minimum of 3 years of post-graduate experience in the biopharmaceutical or pharmaceutical industry Experience in biopharmaceutical or vaccines technologies, research & development and/or manufacturing Preferred Qualifications: Experience in biopharmaceutical technologies and/or manufacturing with a strong technical understanding of process validation, process development, technology transfer, and product lifecycle management. Strong understanding of bioprocesses for drug substance (upstream and downstream) Demonstrated skillset in CMC, including complex regulatory submission and response with a variety of regulatory agencies (FDA, EMA, JP, China etc.) Understanding of GMP principles, regulatory submissions, and appropriate regulatory guidance Strong verbal and written communication skills. Ability to interact with and influence across the entire MSAT organization Strong executive presence and executive presentation skills Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Embraces a team-based culture Demonstrates initiative to solve problems and challenge status quo GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.

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