Manager, IVD Manufacturing

Sekisui Diagnostics, LLC; Charlottetown; Vor Ort; CAD 95.000 - 106.000; Vollzeit

Benefits dieser Stelle

Annual bonus plan

RRSP match

Education reimbursement

Fitness reimbursement

Volunteer time off

Zusammenfassung

Sekisui Diagnostics, LLC is seeking a Manager, IVD Manufacturing in Charlottetown to lead Production and Packaging Operations, ensuring safe and compliant manufacture of IVD products. You will set strategic priorities, develop manufacturing leaders, and drive improvements with cross-functional partners.

Ideal candidates bring 5+ years in regulated manufacturing, strong leadership, and expertise in Lean/Six Sigma, ERP systems, validation, and technology transfer. Advanced degrees are a plus.

Qualifikationen

• Post-secondary degree in a science-related field with 5+ years in regulated manufacturing.
• 5+ years leadership experience in manufacturing operations.
• Experience with Lean, Six Sigma, ERP or manufacturing systems, process validation, technology transfer, and change management assets.

Aufgaben

• Lead Production and Packaging Operations to ensure safe, compliant manufacture of IVD products.
• Provide strategic direction and leadership to Manufacturing and Operations leadership.
• Collaborate with Quality, R&D, Regulatory Affairs, Engineering, Supply Chain and partners to drive improvements and investigations.

Kenntnisse

Leadership

Strategic direction

Cross-functional collaboration

Regulated manufacturing

Ausbildung

Science degree

MBA/MSc asset

Tools

ERP/manufacturing systems

Process validation

Technology transfer

Change management

Lean Manufacturing

Six Sigma

Jobbeschreibung

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.

The anticipated base salary for this position is $95,000 - $106,000. This role may also qualify for annual incentives and/or comprehensive benefits. The actual base salary offered will depend on a variety of factors, including without limitation, the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position.

About us:

At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the‑art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.

Sekisui Diagnostics offers a competitive compensation and benefits package including a generous hourly rate, participation in annual bonus plan, Company match to RRSP, education and fitness reimbursements and paid time off to volunteer.

As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non‑job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.