29 Aug
|
Apotex
|
Bengaluru
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 documentati
📌 Senior Manager (Bengaluru)
🏢 Apotex
📍 Bengaluru