Overview
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).
Key Responsibilities:
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.
Experience Required:
Basic Qualifications include:
• 3 years of experience in glass manufacturing and medical device manufacturing in a ISO certified facility
• Post-secondary education, preferably 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.
About ABK Biomedical Inc.
ABK Biomedical is a clinical-stage medical device company focused on developing innovative therapies for liver tumors, including their investigational Eye90 microspheres for Yttrium-90 radioembolization.
Company Background
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 abkbiomedical.com+1. The company combines expertise in engineering, material science, oncology, medical science, regulatory affairs, and clinical study coordination to advance personalized healthcare in oncology abkbiomedical.com
Key Technology: Eye90 Microspheres
ABK Biomedical’s flagship product, Eye90 microspheres®, is an investigational therapy designed for Yttrium-90 (Y-90) radioembolization, a targeted treatment for liver cancer abkbiomedical.com+1. These microspheres are made from a proprietary, imageable glass composition, allowing direct visualization during procedures to improve precision and treatment efficacy abkbiomedical.com+1. Eye90 is currently under evaluation in the Route90 pivotal FDA IDE clinical trial for hepatocellular carcinoma (HCC) and is not yet FDA-approved for general use abkbiomedical.com+1.
Partnerships and Collaborations
ABK Biomedical has established strategic partnerships to support development and commercialization. Notably, the company has a long-term agreement with the University of Missouri Research Reactor (MURR), which serves as the primary irradiation partner for Eye90 microspheres, ensuring scalable and reliable production of the therapy missouri.edu. This collaboration builds on seven years of prior work and supports global access to novel cancer treatments.
Funding and Growth
In October 2025, ABK Biomedical raised US$35 million in Series D financing, led by J.P. Morgan Life Sciences Private Capital, to support ongoing clinical operations, commercialization preparation, and expansion of manufacturing and supply chain capabilities PR Newswire. The company also holds intellectual property in inorganic polymer microspheres and unique administration systems, reinforcing its position in embolotherapy innovation PR Newswire.
Mission and Vision
ABK Biomedical emphasizes advancing medical innovation and improving patient outcomes. The company fosters a stimulating work environment and collaborates with organizations and individuals with exceptional scientific expertise and ethical standards abkbiomedical.com+1. Their focus is on transforming liver cancer treatment through cutting-edge device technologies and personalized oncology solutions.
Additional Activities
Beyond clinical development, ABK Biomedical actively participates in industry events, such as the GEST Annual Meeting, showcasing Eye90 microspheres and other resorbable microsphere technologies LinkedIn. The company also engages in community and team-building activities, reflecting a dynamic corporate culture LinkedIn.
