MSAT Senior Technology SME

GSK•Marietta, PA

4d•Hybrid

About The Position

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. 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. 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.
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 practice across the network.
Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.