At a Glance
- Tasks: Lead and optimize IVD manufacturing operations while ensuring safety and compliance.
- Company: Join Sekisui Diagnostics, a leader in innovative diagnostic solutions.
- Benefits: Competitive salary, annual bonuses, RRSP matching, and education reimbursements.
- Other info: Diverse workplace committed to equal opportunities and career growth.
- Why this job: Make a real impact in healthcare by improving patient outcomes through diagnostics.
- Qualifications: 5+ years in manufacturing leadership with a science-related degree.
The predicted salary is between 95000 - 106000 $ per year.
As Manager, IVD Manufacturing, you will lead our Production and Packaging Operations in Charlottetown, ensuring the safe, efficient, and compliant manufacture of In Vitro Diagnostic (IVD) products. As a key member of the Operations leadership team, you will provide strategic direction and leadership to Manufacturing, with accountability for performance across safety, quality, delivery, productivity, and cost.
You will lead and develop Manufacturing leaders while fostering a culture of accountability, collaboration, continuous improvement, and operational excellence. Working closely with Quality, R&D, Regulatory Affairs, Engineering, Supply Chain, and other business partners, you will provide both scientific and operational leadership to support manufacturing processes, technical investigations, process improvements, product transfers, validations, and organizational priorities.
You will help ensure ongoing compliance with applicable FDA, Health Canada, ISO, and Quality Management System requirements while maintaining a strong focus on inspection readiness and reliable product supply. To succeed in this role, you will bring strong leadership, scientific knowledge, business acumen, and manufacturing expertise, with the ability to translate business objectives into clear operational priorities.
You should have demonstrated experience leading teams in a regulated manufacturing environment, managing complex investigations and continuous improvement initiatives, and using data and operational metrics to drive sound decision-making. Experience with Lean Manufacturing, Six Sigma, ERP or manufacturing systems, process validation, technology transfer, and change management would be considered an asset.
The ideal candidate will possess a post‑secondary degree in a science‑related discipline such as Biology, Biochemistry, Biotechnology, Chemistry, Biomedical Sciences, or a related field, combined with 5+ years of progressive manufacturing, operations, or production management experience in a regulated environment and a minimum of 5 years of leadership experience. An advanced degree such as an M.Sc. or MBA would be considered an asset. A combination of education and experience will also be considered.
Essential Skills:
- Adaptability
- Oral Communication
- Problem Solving
- Working with Others
Soft Skills:
- Critical Thinking
- Leadership
- Results Oriented
- Team Oriented
Hard Skills:
- Program Development
- Program Evaluation
- Project Management
- Strategic Planning
Languages: English
Manager, IVD Manufacturing in Charlottetown employer: Sekisui Diagnostics P.E.I. Ltd.
Sekisui Diagnostics P.E.I. Ltd. is an exceptional employer that fosters a collaborative and innovative work culture in the heart of Charlottetown. With a strong commitment to employee growth, we offer comprehensive training programs and opportunities for advancement in the dynamic field of in vitro diagnostics. Our focus on quality and compliance ensures that you will be part of a team dedicated to making a meaningful impact in healthcare while enjoying the benefits of a supportive and engaging workplace.
Contact Details:
Sekisui Diagnostics P.E.I. Ltd. Recruitment Team
