Clear Dynamic is revolutionizing pain management through glass microsphere technology. Our proprietary, water-soluble embolic particles provide targeted treatments for patients. Developed using advanced materials engineering, our microspheres are designed to safely dissolve in the body, providing a precise and innovative approach to pain intervention. We are a passionate team, dedicated to improving patient outcomes through groundbreaking materials science. Join us as we shape the future of interventional medicine.
About the Opportunity
As Operations Manager you will play a critical role in supporting ClearDynamic's transition from early feasibility and clinical manufacturing to broader manufacturing and commercialization readiness for medical device products. In this role you will responsible for the day-to-day execution of key operational functions, including facilities and equipment management, calibration and maintenance, materials and inventory control, manufacturing, and oversight of the company's health and safety program. These functions are essential to maintaining compliance with ISO 13485, 21 CFR 820, and local regulatory requirements, and provide the operational foundation necessary to support product realization across the product lifecycle including early feasibility, clinical manufacturing, and commercial scale-up. This hands-on leadership role is well-suited to individuals who thrive in a dynamic environment and are motivated to build robust, compliant operations that enable high-quality product development and company growth.
Key Responsibilities
Facility Operations
- Manage the day-to-day operations of the facility and equipment, including the controlled clinical manufacturing area.
- Contribute to project planning and scheduling by providing operations inputs to support product development timelines.
- Report on performance of operational processes, including development and measurement of KPIs.
- Oversee procurement and supply chain by supporting the sourcing of materials, equipment, and tooling/fixtures, and the controlled selection and approval of suppliers (as appropriate).
- Develop, implement, maintain, and oversee operational processes and their training in accordance with ISO 13485 and 21 CFR820.
- Develop a materials management program, including shipping and receiving and inventory management.
- Ensure that risks in manufacturing operations are identified and mitigated (e.g. pFMEAs).
- Maintain facility readiness, including workspace configuration, control of equipment including qualification, maintenance and calibration, and validated environmental controls and monitoring (as appropriate).
- Manage supplier relationships for facilities management, equipment servicing, calibration, consumables, and outsourced production or testing (as needed).
- Actively participate in product deliverables requiring manufacturing inputs, including design and risk management activities and design reviews,
- Lead or support investigations of NC/CAPAs related to operations.
- Manage operations team member(s) in daily operations; assign tasks, manage performance, and ensure compliance with training requirements.
- Collate, analyze and present results in verbal and written format.
- Lead or coordinate workplace safety inspections/audits and participate in internal and external quality audits.
- Provide operations input into business development activities, including due diligence for partnerships or acquisitions.
- Promote a team culture centred on accountability, transparency, safety, quality, and continuous improvement.
- Maintain confidentiality of sensitive company and product information.
- Perform other related duties as assigned to support business objectives.
Employee Health and Safety
- Develop, establish and maintain a EHS program in accordance with WHMIS, NS Occupational Health and Safety (OHS) requirements and other applicable safety regulations to support a safe workplace including the safe handling and storage of chemicals and hazardous materials, radiation emitting equipment, etc.
- Review operations and EHS records for traceability, adherence to good documentation practices, and compliance with internal and external requirements.
- Drive workplace hazard assessments and enforce the PPE program, ensure chemical spill response readiness, and other identified risk control measures.
- Maintain a system to ensure current SDSs are obtained, organized, and made accessible to staff in work areas where hazardous chemicals are handled.
- Create, review, and maintain QMS and EHS documentation, such as SOPs, work instructions, and forms/templates.
Working/Physical Requirements
- Must be comfortable working in cleanroom or controlled environments, with the ability to don required personal protective equipment (PPE), including lab coats, gloves, masks, and safety glasses.
- Working with hazardous materials and chemicals may be required.
- Ability to work at a computer for prolonged periods.
- Periodic standing for manufacturing activities or audits/inspections.
- Occasional lifting or movement of equipment (up to 50 lbs).
- May require use of step ladders, pallet jacks, or material handling carts.
About You
We would love to hear from you if you have the following:
- BSc in engineering, life sciences, chemistry or related field.
- 2+ years in a supervisory or managerial role.
- Demonstrated experience in maintaining operations, including EHS programs, in a regulated industry preferred.
- Experience working in a cleanroom or other controlled environment preferred.
- Working knowledge of GMPs, GDPs, QMS. ISO 13485, and 21 CFR 820 a strong asset.
- Working knowledge of local occupational health and safety requirements a strong asset.
- Familiarity with equipment qualification and process validation.
- Proven experience managing and interacting with suppliers.
- Strong organizational and problem-solving skills.
- Excellent communication (written and verbal).
- Proficient in MS Office.
- Ability to work cross-functionally and adapt to a dynamic start-up environment.
- Conflict resolution and decision making.
Work with us
At Clear Dynamic, you'll be part of a team that's transforming lives through innovation.
Here's what you can expect when you join us:
Co-paid Health, Dental, and Vision Insurance
We offer comprehensive coverage to support your health and well-being.
Generous Paid Time Off & Holidays
We value work-life balance and encourage time to recharge.
Professional Development Support
Whether it's a course, certification, or conference, we offer reimbursement for training and growth opportunities.
Once You've Applied
Thank you for your interest in this position. Only those applicants selected for an interview will be contacted.
Job Type: Full-time
Pay: From $85,000.00 per year
Work Location: Hybrid remote in Halifax, NS