Lead Scientist, Sterile Drug Packaging & Container Closure

GSK; Upper Providence (Delaware County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Job summary

GSK seeks a Packaging Development professional to support DDS project teams, Clinical and Global Supply Chain across modality types. You will contribute to primary packaging selection, stability campaigns, and documentation for regulatory submissions.

The role emphasizes design control, qualification, and collaboration across internal and external interfaces to ensure cost-effective development and timely product launches.

Qualifications

• BS (+6 years of experience) or MS (+4 years) or PhD (+0 years) noted in the posting.
• Degree in Engineering or related scientific discipline.
• 3+ years of experience developing and implementing packaging solutions.
• 3+ years of experience interpreting and implementing regulatory standards for packaging.

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
• Assessment of new materials, components, and technologies for technical performance and cost effectiveness
• Conduct packaging activities and support development/execution of strategies for package development
• Comply with global harmonized standards and coordinated strategies for pack development activities
• Lead the characterization of container closure systems and compatibility with drug products

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 a Packaging Development professional to support DDS project teams, Clinical and Global Supply Chain across modality types. You will contribute to primary packaging selection, stability campaigns, and documentation for regulatory submissions.

The role emphasizes design control, qualification, and collaboration across internal and external interfaces to ensure cost-effective development and timely product launches.