MSAT Senior Technology SME
GSK
19 days ago
Remote friendly (Marietta, PA)
United States
Operations
Position Summary
- Experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) supporting commercial Drug Substance and Drug Product Vaccine manufacture with technical lifecycle ownership in your area of expertise (mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, AVI). Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness initiatives, and technology transfers from donor sites.
Responsibilities
- Lead technical strategy, troubleshooting, scale-up, process robustness, technology transfers, lifecycle changes, and technical reviews.
- Provide SME leadership for investigations, root cause analysis, CAPA development, 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/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.
- Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.
Qualifications
- Bachelor’s degree in a relevant scientific/engineering discipline (Pharmaceutical Sciences, Chemical Engineering, Biology, Chemistry).
- 5+ years’ experience 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 mixing/homogeneity, chromatography, filtration, ultrafiltration/diafiltration, aseptic processing.
- Experience leading technical investigations, root cause analysis, and CAPA development.
- Data analysis and advanced statistical methods for process understanding.
- Knowledge of GMP and regulatory expectations.
Preferred Qualifications
- Master’s or PhD.
- Experience with sterile manufacturing/aseptic processing.
- Extractables/leachables, material qualification, or supplier component assessments.
- Regulatory expectations for process validation and continued process verification.
- Project leadership and mentoring; Lean/Six Sigma training.
- Experience supporting regulatory inspections and strong technical communication.
Work Arrangement
- Hybrid; on-site regularly for manufacturing readiness and technical transfer work.
Ready to Apply
- Submit your 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) supporting commercial Drug Substance and Drug Product Vaccine manufacture with technical lifecycle ownership in your area of expertise (mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, AVI). Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness initiatives, and technology transfers from donor sites.
Responsibilities
- Lead technical strategy, troubleshooting, scale-up, process robustness, technology transfers, lifecycle changes, and technical reviews.
- Provide SME leadership for investigations, root cause analysis, CAPA development, 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/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.
- Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.
Qualifications
- Bachelor’s degree in a relevant scientific/engineering discipline (Pharmaceutical Sciences, Chemical Engineering, Biology, Chemistry).
- 5+ years’ experience 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 mixing/homogeneity, chromatography, filtration, ultrafiltration/diafiltration, aseptic processing.
- Experience leading technical investigations, root cause analysis, and CAPA development.
- Data analysis and advanced statistical methods for process understanding.
- Knowledge of GMP and regulatory expectations.
Preferred Qualifications
- Master’s or PhD.
- Experience with sterile manufacturing/aseptic processing.
- Extractables/leachables, material qualification, or supplier component assessments.
- Regulatory expectations for process validation and continued process verification.
- Project leadership and mentoring; Lean/Six Sigma training.
- Experience supporting regulatory inspections and strong technical communication.
Work Arrangement
- Hybrid; on-site regularly for manufacturing readiness and technical transfer work.
Ready to Apply
- Submit your resume and a brief note describing a recent technical transfer, validation, or investigation you led or supported.