Packaging Development

Role & responsibilities 1. Develop and select packaging materials for sterile injectables, including BFS products, vials, ampoules, stoppers, seals, foils, cartons, and labels. 2. Lead packaging development, scale-up, validation, and technology transfer activities. 3. Prepare and review packaging qualification documents, including URS, DQ, IQ, OQ, and PQ protocols and reports. 4. Conduct machinability trials, container closure integrity assessments, compatibility studies, and packaging material evaluations. 5. Develop packaging strategies, trade dress, artwork, specifications, drawings, and packaging process flows. 6. Coordinate with cross-functional teams for extractables and leachables, transportation simulation, ink migration, and other packaging studies. 7. Identify and qualify packaging material suppliers and support technical audits. 8. Handle packaging equipment troubleshooting, market complaint investigations, change controls, and CAPA. 9. Support product launches, BOM creation, SOP revisions, regulatory audits, and packaging process training. 10. Ensure compliance with cGMP, EHS, and data integrity requirements. Preferred candidate profile Strong knowledge of sterile injectable packaging development and material selection. Experience in packaging validation, qualification, and technology transfer. Understanding of packaging equipment, artwork development, and regulatory requirements. Proficiency in MS Project, MS Visio, Minitab, and artwork-related software. Excellent communication and technical documentation skills.