Evik Diagnostics Innovations is an Ottawa based ISO 13485:2016 certified manufacturer medical diagnostic assay reagents in lyophilized beads format. Our reagents are used in rapid immunological and molecular diagnostics assays and test devices. We are a high-volume manufacturer offering our customers unprecedented expertise in development, optimization, and validation of lyophilized assay reagents.
JOB DESCRIPTION
The Laboratory Technologist/Coordinator works directly with the Director of R&D and Evik Diagnostics customers to ensure smooth flow of customer projects, schedules and project results. The Laboratory Technologist/Coordinator is responsible for supervising ongoing projects to enhance client satisfaction while ensuring smooth operation of the R&D Laboratory.
KEY RESPONSIBILITIES
- Coordinate contract development projects for Evik Diagnostics customers in Biopharmaceutical and Medical Device industry
- Assisting Director R&D in design of customer specific experimental plans, communicating and negotiating experimental plans with customers in biotechnology and medical device industry
- Scheduling and monitoring of customer specific pharmaceutical and diagnostic assays formulations dispensing in precise microliter size drops, planning and scheduling dispensing experiments.
- Collecting information and SDS on customer specific reagent formulations.
- Assisting in Director R&D in analyzing thermal properties of reagent mix formulation and design freeze-dry cycles
- Communicate project progress and to peers and leadership to support decision-making, and collaborate with Production and Business Development teams to support goals and timelines
- Monitor the receipt, storage and withdrawal of all laboratory reagents and tools
- Maintain the proper functioning and calibration of the lab equipment
- Work closely with team members to provide effective solutions to support laboratory tasks and quality objectives
- Maintain relations with EVIKs clients on a highly professional and technical level. Quickly respond to client inquiries and address client concerns and problems. Most of EVIKs clients are biotechnology, medical device and diagnostic manufacturers
- Write Standard Operating Procedures to comply with the QMS ISO13485
- Assist Director Quality Assurance in maintaining QMS and customer ISO audits
Skills and Qualifications
- Must have a Masters degree in biochemistry or a pharmaceutical discipline
- Must have a minimum of 5 years of experience as a project manager or project coordinator in biotechnology or pharmaceutical field
- Must have a minimum of 5 years of experience dealing with clients in Medical Device or Biopharmaceutical industry
- Must have a minimum of 2 years of experience in lyophilized beads technology
- Must have a minimum of 2 years of experience in QMS maintenance and updates
- Must have a minimum of 2 years of expertise in freeze-drying technology and freeze-dry cycle design in application to biopharmaceutical and diagnostic reagents formulations
- Must have a minimum of 5 years of experience in writing technical reports and standard operational procedures.
- Language of work: English
- Full-time, indefinite term employment
- Hourly rate of $34.07-$36.00, subject to potential annual increases
- Benefits: Health and Dental
- Location of work: Onsite
- Vacation: 2 weeks
Contact [email protected].