Role Objective:

The design, development, and compliance of primary, secondary, and tertiary packaging solutions across Solid Orals, Ophthalmic, Injectable, and Drug-Device Combination Products. Drive cost-optimization, regulatory alignment, and technical execution across internal manufacturing sites and CDMO/CMO partners to ensure seamless product development, submission, and commercial launch.

KEY RESPONSIBILITIES

- Packaging Design & Technology Innovation: Design and develop novel primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmic, Injectable, and Drug-Device Combination Products (including Pen Injectors and Autoinjectors). Evaluate new packaging concepts, emerging technologies, and drive continuous improvement across new and existing product categories.

- Value Engineering & Vendor Management: Identify, evaluate, and execute continuous cost-optimization and value-engineering projects across packaging formats. Lead packaging material and device supplier development, vendor qualification activities, and vendor management.

- Documentation & Technical Specifications: Prepare and review Specifications and Standard Testing Procedures (STPs) for primary packaging materials. Author and review Master Packaging Cards (MPCs), Bill of Materials (BOMs), and Batch Packaging Records (BPRs) for submission and commercial launch batches across USV sites and CDMO/CMO facilities.

- Device Regulatory Compliance & Technical Dossiers: Ensure full compliance with global ISO and USP regulatory standards (ISO 11608, ISO 11040, ISO 13485, ISO 14971, USP <661.1>, USP <661.2>, USP <381>, USP <382>, USP <671>). Prepare and review technical documentation for regulated markets, including Threshold Analysis Reports, Design History Files (DHF), Device Master Records (DMR),



Device History Records (DHR), and Medical Device Reporting (MDR) for 510(k) submissions.

- Risk Management & Testing Execution: Conduct Risk Management activities, Failure Mode and Effects Analysis (FMEA), and Human Factors Equivalency studies. Execute functionality and physical performance testing for solid oral packaging and drug-device combinations per USP and ISO guidelines.

- Regulatory Support: Draft technical responses for regulatory queries and compile briefing packages for target regulatory agencies.

- Machinery & Line Operations: Evaluate packaging line machinery compatibility, lead blister change-part development, conduct equipment trials (FAT/SAT), and optimize packaging processes. Leverage operational knowledge of blister and bottle packaging machines.

- RLD Characterization & Systems: Perform Reference Listed Drug (RLD) / Innovator packaging characterization, trade dress development, and reverse engineering. Maintain hands-on working knowledge and operational execution within SAP and TrackWise systems.

- Batch Oversight: Oversee packaging activities related to submission and commercial launch batches across internal USV manufacturing sites and CDMO/CMO partners.

STAKEHOLDER INTERACTIONType of Interaction: Internal

- Interaction with: Cross-Functional Teams (CFTs) including R&D;, Quality Assurance, Regulatory Affairs, Production, Supply Chain,



and Commercial Operations across USV sites

- Nature of Interaction: Technical review, project tracking, regulatory query response compilation, packaging line trials, and seamless transfer of packaging technologies to production.

Type of Interaction: External
- Interaction with: Contract Development / Manufacturing Organizations (CDMO/CMO counterparts), packaging material suppliers, device vendors, and equipment manufacturers.

- Nature of Interaction: Vendor qualification, equipment trials (FAT/SAT), technical discussions on change-parts, component sourcing, value engineering initiatives, and batch execution tracking.

JOB REQUIREMENTSProfessional Experience and Relevant Skills

Experience: 10 to 12 years of hands-on experience in Pharmaceutical & Medical Device Packaging Development.

Skills: Robust vendor management, project management, technical troubleshooting, cross-functional collaboration, and problem-solving skills.

Technical Expertise:

- In-depth expertise in packaging development for Solid Orals, Ophthalmic, Injectable, and Drug-Device Combination Products (Pen Injectors/Autoinjectors).

- Working knowledge of ISO 11608, ISO 11040, ISO 13485, ISO 14971, USP <661.1>, USP <661.2>, USP <381>, USP <382>, and USP <671>.

- Hands-on experience creating DHFs, DMRs, DHRs, and 510(k) submissions.

- Strong working proficiency in SAP and TrackWise systems.

- Experience with blister/bottle packaging equipment, blister change-part development, and FAT/SAT trials.

Academic Qualifications & Certifications:

- Educational Qualification: Post Graduate Degree or Diploma in Packaging Technology from the Indian Institute of Packaging (IIP) or SIES Institute of Packaging.

📌 Manager- Packaging Development (Maharashtra)
🏢 USV
📍 Maharashtra