Role Objective

The design, development, and regulatory compliance of robust primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmics, Injectables, and Drug-Device Combination Products across USV sites and CDMOs. This role ensures seamless launch execution, cost optimization, vendor qualification, and full compliance with global regulatory standards (ISO/USP)

Key Responsibilities

Design & Innovation: Design and develop primary, secondary, and tertiary packaging solutions for Solid Orals, Ophthalmics, Injectables, and Drug-Device Combination Products (including Pen Injectors and Autoinjectors). Introduce new packaging concepts, technologies, and continuous improvements for new or existing product categories.

Regulatory Compliance & Technical Documentation: 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. Ensure compliance with ISO 11608, ISO 11040, ISO 13485, ISO 14971, USP , USP , USP , USP , and USP . Prepare technical responses for regulatory queries and briefing packages.

Process Optimization & Commercial Execution: Prepare and review Specifications, STPs, MPCs, BOMs, and BPRs for submission and commercial launch batches at USV sites and CDMO/CMO facilities. Oversee packaging activities for submission/launch batches, evaluate packaging line machinery compatibility, lead blister change-part development, conduct equipment trials (FAT/SAT), and optimize line processes.

Value Engineering & Risk Management: Identify, evaluate, and implement continuous cost-optimization and value-engineering projects across packaging formats. Lead Risk Management activities, Failure Mode and Effects Analysis (FMEA), and Human Factors Equivalency studies.

Testing & Characterization: Execute functionality and physical performance testing for solid oral packaging and drug-device combinations. Perform Reference Listed Drug (RLD) / Innovator packaging characterization, trade dress development, and reverse engineering.

Vendor & Systems Management: Lead packaging material and device supplier development and vendor qualification activities. Maintain hands-on operational management using SAP and TrackWise systems.

STAKEHOLDER INTERACTION Type 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 REQUIREMENTS Professional Experience and Relevant Skills

Experience: 8 to 10 years of post-qualification experience in Pharmaceutical & Medical Device Packaging Development.

Technical Expertise

Deep technical expertise in solid orals, injectables, ophthalmics, and drug-device combination products (Pen Injectors/Autoinjectors).

Thorough knowledge of global packaging standards (ISO 11608, ISO 11040, ISO 13485, ISO 14971, USP , USP ).

Hands-on knowledge of blister & bottle packing machines, change-part development, FAT/SAT equipment trials, and line optimization.

Proficiency in generating DHF, DMR, DHR, FMEA, and 510(k) submission documentation.

Hands-on working knowledge of SAP and TrackWise tools.

Skills: Strong cross-functional collaboration, project management, technical writing, problem-solving, and vendor negotiation skills.

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.

Deputy Manager- Packaging Development