MSAT Senior Technology SME

About the role

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).

Responsibilities

• Lead technical strategy, troubleshooting, manufacturing scale-up activities, process robustness initiatives, technology transfers from donor sites for new and established products.
• 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.

Why You?

• Work arrangement: Hybrid. You will be expected to be on-site regularly to support manufacturing and operational readiness activities as well as technical transfer work. Exact on-site vs remote days will be agreed with your manager based on project needs.

Basic Qualification

• 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.

Preferred Qualification

• 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.