MSAT Technology SME

GSK•Marietta, PA

8d•Hybrid

About The Position

You will join Manufacturing Science & Technology (MSAT) as a 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 support technical strategy, troubleshooting, manufacturing scale-up activities, process robustness initiatives, and technology transfers from donor sites for new and established products. We value clear problem solvers who communicate well, act with integrity, and who want to grow while making a real impact on patient supply. This role offers growth, visible impact across global supply, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in a relevant scientific or engineering discipline such as Pharmaceutical Sciences, Chemical Engineering, Biology, or Chemistry.
2+ 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.
Experience using data analysis and basic statistical methods for process understanding.
Knowledge of GMP and regulatory expectations relevant to manufacturing and quality systems.

Nice To Haves

Master’s degree or PhD in a relevant scientific or engineering field.
Experience with sterile manufacturing and aseptic processing.
Familiarity with process control systems, manufacturing informatics or data historians.
Knowledge of regulatory expectations for process validation and continued process verification.
Proven track record of delivering continuous improvement or yield enhancement projects.
Strong written and verbal communication skills and experience preparing technical reports and protocols.

Responsibilities

Support technical strategy, troubleshooting, manufacturing scale-up activities, process robustness initiatives, technology transfers., lifecycle changes and technical reviews.
Support cross functional teams 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.
Support the deployment of 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 to build skills.
Support continuous improvement by identifying technical improvements and supporting implementation.