Urgent Opening For Assistant Manager - Packaging development (R&D)

Role & responsibilities

Position: Assistant Manager Packaging Development (R&D)

Department: Research & Development Packaging Development
Designation: Assistant Manager
Location: MSN Laboratories R&D
Experience: 8–12 Years
Qualification: Packaging Technology

1. Job Purpose

To manage and execute packaging development activities for pharmaceutical products, ensuring the selection, development, qualification, and optimization of packaging components in compliance with regulatory, quality, and product requirements.

2. Key Responsibilities

• Lead packaging development activities for pharmaceutical products from concept to commercialization.
• Develop and evaluate primary, secondary, and tertiary packaging components based on product requirements.
• Identify and evaluate suitable packaging materials such as bottles, blisters, strips, tubes, sachets, pouches, vials, cartons, labels, foils, closures, and other components.
• Coordinate with Formulation R&D, Analytical R&D, Quality Assurance, Regulatory Affairs, Production, Procurement, and vendors for packaging development activities.
• Prepare and review packaging development specifications, component drawings, artwork, technical documents, and packaging BOMs.
• Conduct packaging component trials, compatibility studies, line trials, and packaging optimization activities.
• Evaluate packaging materials for suitability, functionality, stability, protection, and product compatibility.
• Support development and qualification of packaging components and suppliers.
• Participate in packaging-related investigations, deviations, change controls, CAPA, and root-cause analysis.
• Support stability studies and packaging compatibility evaluations as required for product development and regulatory submissions.
• Ensure packaging development activities comply with applicable GMP, regulatory, quality, and safety requirements.
• Review technical information and specifications received from packaging material suppliers.
• Coordinate with vendors for development of new packaging components, samples, tooling, trials, and technical documentation.
• Evaluate packaging components for manufacturability, machinability, dimensional accuracy, and performance on packaging lines.
• Support scale-up, technology transfer, exhibit batches, registration batches, and commercial launch activities.
• Prepare and maintain packaging development reports, protocols, specifications, trial reports, and technical records.
• Provide technical support for resolving packaging-related issues encountered during manufacturing and commercial operations.
• Identify opportunities for cost optimization, material standardization, sustainability, and packaging improvement.
• Mentor junior team members and ensure timely completion of assigned packaging development projects.

3. Regulatory & Compliance Responsibilities

• Ensure packaging development documentation meets applicable regulatory requirements.
• Support preparation and review of packaging-related information for CTD/eCTD dossiers, regulatory submissions, and customer requirements.
• Maintain compliance with applicable pharmacopoeial and regulatory standards, including USP, EP, IP, FDA, EMA, and other relevant guidelines.
• Ensure appropriate documentation and traceability of packaging components and development activities.
• Participate in internal, customer, and regulatory audits related to packaging development when required.

4. Required Technical Skills

• Strong knowledge of pharmaceutical packaging materials and technologies.
• Good understanding of primary and secondary packaging systems.
• Knowledge of blister, bottle, strip, tube, sachet, pouch, vial, and carton packaging.
• Knowledge of packaging material specifications, drawings, artwork, and BOM preparation.
• Understanding of packaging compatibility, stability, moisture/oxygen/light protection, and material selection.
• Knowledge of packaging line trials, machine compatibility, and troubleshooting.
• Familiarity with packaging component qualification and supplier evaluation.
• Knowledge of GMP, GDP, change control, deviation, CAPA, and risk assessment principles.
• Good analytical, problem-solving, documentation, and project-management skills.
• Good communication and cross-functional coordination abilities.

5. Key Competencies

• Packaging Development & Innovation
• Technical Problem Solving
• Project Management
• Vendor Management
• Regulatory & GMP Compliance
• Cross-functional Collaboration
• Documentation & Reporting
• Team Leadership
• Decision Making
• Attention to Detail

6. Preferred Experience

Candidates with experience in pharmaceutical packaging R&D/development, particularly in generic formulations, oral solid dosage forms, sterile products, or regulated-market pharmaceutical development, will be preferred.

Experience in handling new packaging development, packaging optimization, vendor coordination, line trials, stability/compatibility studies, and technology transfer will be an added advantage.