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Senior Manager- Device & Packaging Technology

Apotex
Apotex
12-18 years
Not Disclosed
Bangalore, Karnataka, India
10 March 8, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Manager – Device & Packaging Technology

Company: Apotex Inc.
Location: Bangalore, Karnataka, India – 560099
Job Type: Full-Time
Experience Required: 12–18 Years
Education: Master’s Degree or PhD in Mechanical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Polymer/Material Science, Chemical Engineering, or a related discipline

About Apotex
Apotex Inc. is a Canadian-based global health company committed to improving access to affordable and innovative medicines for patients worldwide. The company develops and manufactures a broad portfolio of pharmaceutical products including generic medicines, biosimilars, innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto, Canada, Apotex operates globally with regional offices in the United States, Mexico, India, and other international markets. The company is recognized as the largest Canadian-based pharmaceutical organization and a trusted partner for pharmaceutical licensing and product acquisition.

Job Summary
The Senior Manager – Device & Packaging Technology is responsible for leading laboratory and technical activities related to the development of primary and secondary packaging components for a variety of liquid dosage forms including injectables, ophthalmic products, and nasal sprays. The role also focuses on the design, development, and commercialization of drug delivery devices and combination products. This position combines strong technical expertise with leadership responsibilities to drive innovation, ensure regulatory compliance, and build a high-performing Device Development team.

Key Responsibilities
Lead the development of combination drug-device products such as autoinjectors, wearable injectors, and prefilled syringes from concept through commercialization.
Translate Target Product Profiles (TPPs) into device specifications and design inputs aligned with product requirements.
Oversee design control processes including design verification, validation, risk management in accordance with ISO 14971, and usability engineering following IEC 62366 guidelines.
Ensure compliance with regulatory requirements including FDA 21 CFR Part 820, ISO 13485, EU MDR, and 21 CFR Part 4.
Provide leadership and mentorship to the Device Development team to support innovation and operational excellence.
Recruit, train, and develop talent while building a high-performing technical team.
Establish departmental goals and align them with broader organizational strategies.
Represent the Device Development function in cross-functional meetings and leadership forums.
Collaborate with Regulatory Affairs, Quality Assurance, Manufacturing, Clinical, and Human Factors teams.
Serve as the primary liaison with Contract Development and Manufacturing Organizations (CDMOs).
Support regulatory submissions including IND, NDA, BLA, and 510(k).
Manage multiple device development projects, ensuring timely completion and adherence to budget requirements.
Develop project timelines, budgets, and risk mitigation strategies.
Lead troubleshooting and resolution of technical and manufacturing challenges.
Prepare and review technical documentation including development protocols, validation reports, and regulatory documentation.
Present technical updates and strategic insights to senior leadership and stakeholders.
Manage departmental budgets, resources, and performance metrics.
Ensure compliance with corporate ethics, quality policies, safety standards, and HR policies while promoting a culture aligned with Apotex core values of Collaboration, Courage, Perseverance, and Passion.

Required Skills and Competencies
Strong knowledge of pharmaceutical packaging materials including COP/COC polymers, plastics, and glass used in drug delivery systems.
Solid understanding of device development processes and combination product regulations.
Experience working with laboratory testing and pharmaceutical packaging development practices.
Proficiency in Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
Excellent analytical, organizational, and technical documentation skills.
Strong verbal and written communication skills in English.
Ability to collaborate effectively with cross-functional teams in a regulated pharmaceutical environment.

Experience Required
Candidates should have 12–18 years of professional experience in pharmaceutical research and development, particularly in the development of combination drug-device products for sterile pharmaceutical formulations. A minimum of 5 years of experience in a leadership or managerial role is required. Experience working within GMP and GLP regulated environments is essential, and laboratory experience with relevant pharmaceutical development guidelines is highly preferred.

Equal Opportunity Statement
Apotex is committed to fostering an inclusive and accessible workplace where employees feel valued, respected, and supported. The company provides accommodations for applicants with disabilities throughout the recruitment process. Candidates who require assistance during interviews or assessments are encouraged to inform the recruitment team.