MSAT Senior Technology SME
GSK
July 02, 2026
Remote friendly (Marietta, PA)
United States
Operations
Position Summary
- Experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) in the United States, providing technical lifecycle ownership to support commercial Drug Substance and Drug Product Vaccine manufacture (e.g., mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, AVI). Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness, and technology transfers from donor sites for new and established products.
Responsibilities
- Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness, technology transfers, lifecycle changes, and technical reviews.
- Provide SME leadership for investigations, root cause analysis, CAPA, and regulatory responses.
- Translate lab/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.
- Provide technical input to change controls, risk assessments, and corrective actions.
- Train, coach, and mentor cross-functional teams and MSAT peers; share best practices.
- Drive continuous improvement by identifying technical improvements, implementing, and tracking outcomes.
Work arrangement
- Hybrid; expected on-site regularly. Exact on-site vs remote days agreed with manager.
Basic Qualifications (Required)
- Bachelor’s in a relevant scientific/engineering discipline.
- 5+ years in pharmaceutical vaccines/biologics manufacturing technical operations.
- Hands-on experience with technology transfers, scale-up, process validation, lifecycle management in regulated environments.
- Practical knowledge of unit operations (mixing/homogeneity, chromatography, filtration, UF/DF, aseptic processing).
- Experience leading technical investigations, RCA, and CAPA development.
- Data analysis and advanced statistical methods for process understanding.
- Knowledge of GMP and regulatory expectations.
Preferred Qualifications
- Master’s/PhD; sterile manufacturing/aseptic processing; extractables/leachables/material qualification/supplier assessments; regulatory expectations for validation and continued process verification; mentoring and cross-functional project leadership; Lean/Six Sigma or other training; regulatory inspection support; strong written/verbal communication.
Application instructions
- Submit resume and a brief note describing a recent technical transfer, validation, or investigation you led or supported.
- Experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) in the United States, providing technical lifecycle ownership to support commercial Drug Substance and Drug Product Vaccine manufacture (e.g., mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, AVI). Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness, and technology transfers from donor sites for new and established products.
Responsibilities
- Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness, technology transfers, lifecycle changes, and technical reviews.
- Provide SME leadership for investigations, root cause analysis, CAPA, and regulatory responses.
- Translate lab/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.
- Provide technical input to change controls, risk assessments, and corrective actions.
- Train, coach, and mentor cross-functional teams and MSAT peers; share best practices.
- Drive continuous improvement by identifying technical improvements, implementing, and tracking outcomes.
Work arrangement
- Hybrid; expected on-site regularly. Exact on-site vs remote days agreed with manager.
Basic Qualifications (Required)
- Bachelor’s in a relevant scientific/engineering discipline.
- 5+ years in pharmaceutical vaccines/biologics manufacturing technical operations.
- Hands-on experience with technology transfers, scale-up, process validation, lifecycle management in regulated environments.
- Practical knowledge of unit operations (mixing/homogeneity, chromatography, filtration, UF/DF, aseptic processing).
- Experience leading technical investigations, RCA, and CAPA development.
- Data analysis and advanced statistical methods for process understanding.
- Knowledge of GMP and regulatory expectations.
Preferred Qualifications
- Master’s/PhD; sterile manufacturing/aseptic processing; extractables/leachables/material qualification/supplier assessments; regulatory expectations for validation and continued process verification; mentoring and cross-functional project leadership; Lean/Six Sigma or other training; regulatory inspection support; strong written/verbal communication.
Application instructions
- Submit resume and a brief note describing a recent technical transfer, validation, or investigation you led or supported.