MSAT Senior Technology SME

GSK•Marietta, PA

8d•Hybrid

About The Position

We are seeking an experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) in the United States. This role involves collaborating with technical, quality, and other partners to support commercial Drug Substance and Drug Product Vaccine manufacture. You will have technical lifecycle ownership in your area of expertise, including mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, and AVI. Your responsibilities will include leading technical strategy, troubleshooting, manufacturing scale-up activities, process robustness initiatives, and technology transfers from donor sites for both new and established products. We are looking for clear problem solvers who communicate effectively, act with integrity, and are eager to grow while making a significant impact on patient supply. This position offers opportunities for growth, visible impact across global supply, and the chance to contribute to GSK's mission of uniting science, technology, and talent to get ahead of disease.

Requirements

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.

Nice To Haves

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 (for example 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.

Responsibilities

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 practices across the network.
Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.