Senior Manager- Device & Packaging Technology
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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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
- Masters 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
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Required Experience:
Senior Manager
Key Skills
- Brewing
- FDA Regulations
- Food Industry
- Food Safety Experience
- Packaging
- Clinical Trials Management
- 5S
- Plastics Blow Molding
- Food Processing
- Microsoft Project
- cGMP
- Logistics
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
