Senior Manager- Device & Packaging Technology

Job Summary

The Senior Manager-Device & Packaging Technology, is responsible for lab activities for the development of primary, secondary and associated packaging components for a large variety of liquid dosage forms including Injectables, Ophthalmic, Nasal spray etc. eads the design, development, and commercialization of drug delivery devices and combination products. This role combines technical expertise with strategic leadership to drive innovation, ensure regulatory compliance, and foster a high-performing team culture within the Device Development group.

Job Responsibilities

• Lead the development of combination products (e.g., autoinjectors, wearable injectors, prefilled syringes) from concept through commercialization.
• Translate Target Product Profiles (TPPs) into device specifications and design inputs.
• Oversee design control activities including design verification/validation, risk assessments (ISO 14971), and usability engineering (IEC 62366).
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and 21 CFR Part 4.
• Provide strategic direction and mentorship to the Device Development team.
• Build and manage a high-performing team by recruiting, training, and developing talent.
• Foster a culture of innovation, accountability, and continuous improvement.
• Set departmental goals and ensure alignment with broader organizational objectives.
• Represent the Device Development function in cross-functional leadership forums and governance meetings.
• Collaborate with Regulatory, Quality, Manufacturing, Clinical, and Human Factors teams.
• Serve as the primary liaison with Contract Development and Manufacturing Organizations (CDMOs).
• Support regulatory submissions (IND, NDA, BLA, 510(k)).
• Lead multiple device development projects, ensuring timely delivery and budget adherence.
• Develop and manage project timelines, budgets, and risk mitigation strategies.
• Lead troubleshooting and resolution of technical and manufacturing issues.
• Author and review technical documentation, including protocols, reports, and regulatory dossiers.
• Present technical and strategic updates to internal and external stakeholders, including senior leadership.
• Develop and manage departmental budgets, resource planning, and performance metrics. Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education

• Master’s degree/ PhD in Mechanical, Biomedical, Pharmaceutical Sciences, Polymer Science/Material Science/Chemical Engingeering or related science

• Knowledge, Skills and Abilities
  • Knowledge of common packaging materials like COP/COC, plastics and glass
  • Experience using computers, preferably in Microsoft Office (Word, Excel, PowerPoint and Outlook)
  • Excellent organization and report writing skills
  • Strong verbal and written English communication skills

• Experience
  • Over 12 to 18 years of working experience on combination devices for sterile products in a pharmaceutical research and development environment.
  • 5+ years in a leadership or managerial role. Knowledge of GMP, GLP environment & requirements in a pharmaceutical company.
  • Experience on working in lab and understanding of relevant guidelnes/practices will be preferred