Deputy Manager- Packaging Development

Bioksha; Maharashtra; On-site; INR 2,000,000 - 3,000,000; Full time

Job summary

Bioksha in Maharashtra, India is seeking an experienced Packaging Development Leader to drive design, development, and regulatory compliance for solid oral, ophthalmic, injectable, and drug-device packaging across sites and CDMOs.

You will optimize costs, qualify vendors, and ensure global regulatory standards (ISO/USP) are met, coordinating with R&D, QA, Regulatory Affairs, Production, and Supply Chain for seamless launches.

Qualifications

• Experience: 8 to 10 years in Pharmaceutical & Medical Device Packaging Development.
• Deep knowledge of global packaging standards (ISO 11608, ISO 11040, ISO 13485, ISO 14971, 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.

Responsibilities

• Design and develop primary, secondary, and tertiary packaging for Solid Orals, Ophthalmics, Injectables, and Drug-Device products (including Pen Injectors and Autoinjectors).
• Introduce new packaging concepts, technologies, and improvements for existing product categories.
• Prepare and review specifications, STPs, MPCs, BOMs, and BPRs for submission and launch batches.
• Oversee packaging activities for submission/launch batches, evaluate line machinery, lead blister change-part development, and conduct equipment trials (FAT/SAT).
• Lead cost-optimization and value-engineering projects; manage risk with FMEA and related studies.
• Maintain SAP and TrackWise data handling and vendor qualification activities.

Skills

Cross-functional collaboration

Project management

Technical writing

Problem-solving

Vendor negotiation

Education

Post Graduate Degree or Diploma in Packaging Technology

Tools

SAP

TrackWise

Job description

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.