Senior Specialist, Drug Product Packaging

As Senior Specialist, Drug Product Packaging, you will create artwork files for production and regulatory submissions, maintain and update existing packaging materials, and collaborate with Regulatory Affairs on documentation updates. You will report to the Senior Director of Drug Product Packaging.

Requirements

• Create artwork files for production and regulatory submissions, including launch materials.
• Maintain and update existing packaging materials.
• Collaborate with Regulatory Affairs on documentation updates.
• Provide SME support for the design, verification, and implementation of packaging solutions.
• Develop technical requirements and specifications for packaging components and concepts.
• Collaborate with external partners and CMOs.
• Assess and provide SME input to CMO change controls, deviations, and CAPAs related to packaging.
• Manage life‐cycle activities and conduct root‐cause analyses for commercial packaging issues.
• Plan and execute internal change controls.
• Contribute to manufacturing transfers by defining production‐ready specifications.

Benefits

• Generous Paid Time Off
• 401k Matching
• Relocation Assistance