Global Molecule Steward: Technical Lifecycle Leader

GSK; Collegeville (PA); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Hybrid work model

Comprehensive benefits

Job summary

GSK is seeking an experienced Molecule Steward to own end-to-end technical accountability for a product across bulk API manufacturing, formulation, packing, and support activities. You will provide strategic leadership to ensure quality, robustness, and lifecycle improvements, aligned with the Product Control Strategy and MSAT governance.

You will coordinate across Drug Substance, Drug Product, Analytical Strategy, and Device leads, and drive continuous verification, tech strategy, and

Qualifications

• University degree in Chemistry, Chemical engineering, Pharmaceutical Sciences or similar area.
• Extensive years’ experience in small molecule pharmaceutical development and/or manufacturing.
• Comprehensive knowledge of MHRA, FDA regulatory requirements and quality/safety standards.
• Experience in technology transfer and product development processes.
• Knowledge of regulatory strategies and Product Lifecycle Management.
• Experience leading technical lifecycle activities and investigations.

Responsibilities

• Represent MSAT as technical single-point accountable decision maker in CMC and supply chain teams.
• Define End-to-End Product Performance Qualification and ongoing verification strategies.
• Maintain product lifecycle knowledge and drive improvement plans across manufacturing, analytics, packaging, and devices.
• Provide SME leadership for investigations, deviations, and major change programs.
• Coordinate regulatory submission reviews and responses within MSAT with SMEs and sites.

Skills

Chromatography

Regulatory Knowledge

Problem Solving

Cross-functional Collaboration

Education

University Degree in Chemistry/Chemical Engineering/Pharmaceutical Sciences

Job description

GSK is seeking an experienced Molecule Steward to own end-to-end technical accountability for a product across bulk API manufacturing, formulation, packing, and support activities. You will provide strategic leadership to ensure quality, robustness, and lifecycle improvements, aligned with the Product Control Strategy and MSAT governance.

You will coordinate across Drug Substance, Drug Product, Analytical Strategy, and Device leads, and drive continuous verification, tech strategy, and