MSAT Technology SME
GSK
18 days ago
Remote friendly (Marietta, PA)
United States
Operations
Position Summary
Technology Subject Matter Expert (SME) in Manufacturing Science & Technology (MSAT) supporting commercial Drug Substance and Drug Product Vaccine manufacturing with technical lifecycle ownership in mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, and AVI. Support technical strategy, troubleshooting, manufacturing scale-up, process robustness, and technology transfers.
Responsibilities
- Support technical strategy, troubleshooting, manufacturing scale-up, process robustness, technology transfers, lifecycle changes, and technical reviews.
- Lead/support investigations, root cause analysis, CAPA, and regulatory responses.
- Translate lab/development knowledge into robust, scalable manufacturing processes.
- Design and run experiments for characterization, optimization, and validation.
- Support inspection readiness and audits.
- Deploy process control strategies, performance standards, and lifecycle monitoring.
- Provide input to change controls, risk assessments, and corrective actions.
- Train, coach, and mentor cross-functional teams.
- Drive continuous improvement by identifying and implementing technical improvements.
Work Arrangement
Hybrid; on-site regularly as needed for manufacturing readiness and technical transfer.
Basic/Required Qualifications
- Bachelor’s degree in a relevant scientific/engineering discipline (e.g., Pharmaceutical Sciences, Chemical Engineering, Biology, Chemistry).
- 2+ years’ experience in pharmaceutical vaccines/biologics manufacturing technical operations.
- Hands-on technology transfer, scale-up, process validation, and lifecycle management in a regulated environment.
- Practical unit operations knowledge (mixing/homogeneity, chromatography, filtration, UF/DF, aseptic processing).
- Data analysis and basic statistics for process understanding.
- GMP and regulatory expectations knowledge.
Preferred Qualifications
- Master’s or PhD.
- Sterile manufacturing/aseptic processing experience.
- Process control systems, manufacturing informatics, or data historians.
- Regulatory expectations for process validation/continued process verification.
- Continuous improvement/yield enhancement track record.
- Strong written/verbal communication; prepare technical reports/protocols.
Application Instructions
Submit your application and describe how you would contribute to MSAT and its mission of uniting science, technology, and talent to get ahead of disease together.
Technology Subject Matter Expert (SME) in Manufacturing Science & Technology (MSAT) supporting commercial Drug Substance and Drug Product Vaccine manufacturing with technical lifecycle ownership in mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling, and AVI. Support technical strategy, troubleshooting, manufacturing scale-up, process robustness, and technology transfers.
Responsibilities
- Support technical strategy, troubleshooting, manufacturing scale-up, process robustness, technology transfers, lifecycle changes, and technical reviews.
- Lead/support investigations, root cause analysis, CAPA, and regulatory responses.
- Translate lab/development knowledge into robust, scalable manufacturing processes.
- Design and run experiments for characterization, optimization, and validation.
- Support inspection readiness and audits.
- Deploy process control strategies, performance standards, and lifecycle monitoring.
- Provide input to change controls, risk assessments, and corrective actions.
- Train, coach, and mentor cross-functional teams.
- Drive continuous improvement by identifying and implementing technical improvements.
Work Arrangement
Hybrid; on-site regularly as needed for manufacturing readiness and technical transfer.
Basic/Required Qualifications
- Bachelor’s degree in a relevant scientific/engineering discipline (e.g., Pharmaceutical Sciences, Chemical Engineering, Biology, Chemistry).
- 2+ years’ experience in pharmaceutical vaccines/biologics manufacturing technical operations.
- Hands-on technology transfer, scale-up, process validation, and lifecycle management in a regulated environment.
- Practical unit operations knowledge (mixing/homogeneity, chromatography, filtration, UF/DF, aseptic processing).
- Data analysis and basic statistics for process understanding.
- GMP and regulatory expectations knowledge.
Preferred Qualifications
- Master’s or PhD.
- Sterile manufacturing/aseptic processing experience.
- Process control systems, manufacturing informatics, or data historians.
- Regulatory expectations for process validation/continued process verification.
- Continuous improvement/yield enhancement track record.
- Strong written/verbal communication; prepare technical reports/protocols.
Application Instructions
Submit your application and describe how you would contribute to MSAT and its mission of uniting science, technology, and talent to get ahead of disease together.