MSAT Senior Technology SME

Position Summary

You will be an experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) in the United States. You will work across technical, quality and other partners to support commercial Drug Substance and Drug Product Vaccine manufacture with technical lifecycle ownership in your area of expertise (i.e. mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling and AVI). You will lead technical strategy, troubleshooting, manufacturing scale‑up activities, process robustness initiatives and technology transfers from donor sites for new and established products.

• Lead technical strategy, troubleshooting, manufacturing scale‑up activities, process robustness initiatives, technology transfers, lifecycle changes and technical reviews.
• Provide SME leadership for investigations, root cause analysis, corrective and preventive actions, and regulatory responses.
• Translate lab and development knowledge into robust, scalable manufacturing processes.
• Design and run experiments for process characterization, optimization and validation.
• Support inspection readiness and audit activities.
• Define and deploy process control strategies, performance standards, and lifecycle monitoring for manufacturing processes.
• Provide technical input to change controls, risk assessments and corrective actions.
• Train, coach, and mentor cross‑functional teams and MSAT peers to build capability and share best practice across the network.
• Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.

• Bachelor’s degree in a relevant scientific or engineering discipline such as Pharmaceutical Sciences, Chemical Engineering, Biology, or Chemistry.
• 5+ years’ experience in pharmaceutical vaccines or biologics manufacturing technical operations.
• Hands‑on experience with technology transfers, scale‑up, process validation, and lifecycle management in a regulated environment.
• Practical knowledge of unit operations such as mixing/homogeneity, chromatography, filtration, ultrafiltration/diafiltration, and aseptic processing.
• Demonstrated experience leading technical investigations, root cause analysis, and CAPA development.
• Experience using data analysis and advanced statistical methods for process understanding.
• Knowledge of GMP and regulatory expectations relevant to manufacturing and quality systems.

• Advanced degree (Master’s or PhD) in a relevant field.
• Experience with sterile manufacturing and aseptic processing.
• Background in extractables and leachable, material qualification, or supplier component assessments.
• Knowledge of regulatory expectations for process validation and continued process verification.
• Experience leading cross‑functional projects and mentoring technical teams.
• Formal training in project management, risk management or continuous improvement methods (Lean or Six Sigma).
• Proven track record of leading cross‑functional teams and influencing in a matrix environment.
• Experience preparing for and supporting regulatory inspections and responses.
• Strong written and verbal communication skills for clear technical reporting and stakeholder engagement.

• Practical, clear communication and a collaborative mindset.
• Curiosity and a willingness to learn and share knowledge.
• A focus on patient safety, quality and continuous improvement.
• An inclusive approach that values different perspectives and experiences.

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 (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.