Senior Scientist - Sterile Drug Packaging & Development

GSK; Collegeville (PA); On-site; USD 110,000 - 140,000; Full time

Job summary

GSK seeks professionals to provide packaging support to the DDS project teams, Clinical Supply Chain, and Global Supply Chain across modality types.

The role involves developing primary packaging components, stability campaigns, and validation testing, plus authoring regulatory sections and design controls to ensure compliant product packaging. Collaboration across teams will drive timely development and launch.

Qualifications

• BS, MS or PhD with strong packaging development experience.
• 3+ years developing and implementing packaging solutions.
• 3+ years interpreting/regulating packaging standards.

Responsibilities

• Ensure development requirements to support qualification, registration, and launch key events are met.
• Author IND/NDA CTX/MAA Container Closure sections with supporting documentation.
• Author design control documentation
• Assess new materials, components, and technologies for performance and cost.
• Conduct packaging activities and support development/strategies across multiple teams
• Comply with global standards for pack development
• Lead characterization of container closure system for compatibility
• Support regulatory, quality, and legislative packaging strategies.

Skills

Drug Delivery

External Manufacturing

Medical Device Evaluation

Molecular Modeling

Pharmaceutical Formulations

Pharmacokinetics

Product Design

Product Management

Product Planning

Product Strategies

Quality by Design

Regulatory Filings

Stability Testing

Technology Transfer

Education

BS in Engineering or related field

MS in Engineering or related field

PhD in Engineering or related field

Job description

GSK seeks professionals to provide packaging support to the DDS project teams, Clinical Supply Chain, and Global Supply Chain across modality types.

The role involves developing primary packaging components, stability campaigns, and validation testing, plus authoring regulatory sections and design controls to ensure compliant product packaging. Collaboration across teams will drive timely development and launch.