Manufacturing Specialist
ABK Biomedical Inc. is a clinical-stage medical device company focused on developing innovative therapies for liver tumors, including their investigational Eye90 microspheres for Yttrium-90 radioembolization.
Founded in 2012, ABK Biomedical is dedicated to researching, developing, and commercializing breakthrough medical device therapies aimed at improving outcomes for patients with benign and malignant hypervascular tumors. The company combines expertise in engineering, material science, oncology, medical science, regulatory affairs, and clinical study coordination to advance personalized healthcare in oncology.
ABK Biomedical is currently seeking a Manufacturing Specialist (NOC 33101) to support our ongoing operations.
Business Address / Location of employment: 155 Chain Lake Drive, suite 32, Halifax, NS B3S 1B3
Number of Positions: 1
Terms of Employment: Permanent, full-time position.
Hours: 37.5 hours per week
Salary: $58,350 annually
Benefits:
· Health care plan including vision;
· Dental plan;
· Eligible to participate in company’s discretionary bonus program.
Language of Work: English
Start Date: As soon as possible
Job Responsibilities:
The Manufacturing Specialist shall support day-to-day manufacturing and inspection activities of ABK Biomedical products and the introduction of new product lines compliance with good manufacturing practices (GMPs).
The key responsibilities of the Manufacturing Specialist are as follows:
· Perform routine, high-temperature manufacture of glass microspheres by following released procedures.
· Perform precise and repeatable assembly of medical devices in a certified cleanroom based environment.
· Conduct materials characterization and inspections on in-process and finished product to ensure product meets specification and standards.
· Ensure that products meet the highest standard of quality and are produced on schedule.
· Generate and complete required documentation for the Device History Record (DHR) in a timely manner with adherence to good documentation practice (GDP).
· Offer suggestions on improvement of processes and methods.
· Assist in creating and updating process and product documentation.
· Provide support to teams, including performing non-routine duties related to quality improvement, cost/cycle reduction, method development/improvement, process optimization studies, validation projects or new product introduction.
· Keep work areas clean, organized and safe.
· Perform all duties safely and in compliance with the US FDA Quality System Regulations, Canadian Medical Device Regulations, and all other regulatory requirements with which ABK Biomedical complies.
· Adhere to ABK Biomedical procedures, including quality and safety procedures.
· Communicate observations and data regularly in meetings and reports.
· Must be available to work overtime as requested by management in order to meet business needs.
Qualifications:
· 3 years of experience in glass manufacturing and medical device manufacturing in a ISO certified facility
· College-level diploma in a technical/science discipline.
· Self-motivated, with the ability to multi-task and work without direct supervision.
· The ability to work cohesively with a cross-functional team in a fast-paced environment.
· Excellent analytical, training and communication (verbal and written) skills.
· Excellent listening skills and razor-sharp attention to detail.
· Willing and able to master new skills.
· Strong mechanical aptitude, dexterity and eye-hand coordination.
· The ability to reach, bend and lift daily, and work with a high-temperature oven, materials and open flame.
· Proficient with various types of software.
Desirable Qualifications include:
· Experience working in a regulated manufacturing environment, preferably with ISO 9001 or ISO 13485 certification.
· Previous experience with the following materials characterization techniques: XRD, DSC, helium pycnometry, and SEM
Work Environment and physical capabilities:
· Repetitive tasks
· Manual dexterity
· Attention to detail
· Sitting
· Combination of sitting, standing, walking
· Standing for extended periods
· Fast-paced environment
Bring your resume to 155 Chain Lake Drive, suite 32, Halifax, NS B3S 1B3 or send your resume to [email protected].
We appreciate your interest in our company. Only those candidates selected for an interview will be contacted.
Job Types: Full-time, Permanent
Pay: $58,350.00 per year
Benefits:
- Dental care
- Extended health care
Work Location: In person
