Asst. Manager/ Manager For Packaging Development

Role & responsibilities

We are seeking a highly skilled and experienced professional to lead end-to-end Packaging & Device Development for Injectables. In this role, you will drive the strategy, development, qualification, and implementation of robust packaging solutions and Drug-Device Combination Products (DDCP).

Key Responsibilities

1. Device & Combination Product Development

• End-to-End Solutions
• Strategic Partnerships
• Cross-Functional Alignment

2. Regulatory, Compliance & Quality Systems

• Documentation Management
• Standards & Guidelines
• Audits & Submissions

3. Laboratory Testing, Characterization & Analytics

• Device Functionality Testing
• Analytical Evaluation
• Needle Penetration, Device Injection & Actuation Forces
• Injectability, Syringeability, Dose Accuracy, and Deliverable Volume
• Analytical Characterization

Preferred candidate profile

• Education: Bachelors / Master’s degree in Packaging Technology from IIP, Biomedical Engineering, Mechanical Engineering, Pharmaceutical Sciences, or a related technical discipline.
• Experience: 8–14 years of proven experience in medical device development or injectable packaging design within the pharmaceutical/biotech industry.
• Technical Expertise: Deep knowledge of device ecosystems, component materials (glass, elastomers, plastics), and automation packaging lines.
• Regulatory Knowledge: Clear understanding of 21 CFR Part 820, EU MDR, and combination product approval pathways.
• Soft Skills: Strong project management abilities, cross-functional leadership, analytical thinking, and excellent technical writing skills.