CAREER
Immuni T is a leading contract research organization (CRO) with many years of experience in giving valuable scientific advice to Biotech and Pharma companies by performing variable assays that helped their pre-clinical and clinical projects to be a true success.
Immuni T services are well suited for immunotherapies by the design of cell-based assays complemented by cytometry analysis monitoring the activity of interest. Of our interest is our ex vivo method for assessing the immunogenic potential of novel molecules and variants using freshly-collected PBMCs.
At Immuni T , we value our people and working as a team to achieve our common goals is our passion. Join our great team of experts and bring your talent and apply your knowledge and at the same time seek experience from our dedicated and talented individuals who already contribute in our success.
COMMITMENT TO EQUAL OPPORTUNITY
Immuni T provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity.
Quality Assurance Specialist (QA)
Reporting to the Higher Manager, the QA Manager’s key role is to ensure the integrity of the ImmuniT’s Quality Management System (QMS) and ensures that the entire team are following the Canadian Food and Drugs Regulations. This function maintains quality compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Immuni T Standard Operating Procedures (SOPs). Primary Duties and Responsibilities • Responsible for overseeing, planning and performing GLP/GCP compliance activities. Conduct documented study-, process-, and facility-based inspections to verify compliance to FDA Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) (FDA GLP), OECD Principles of Good Laboratory Practice (OECD GLP), ICH Guideline for Good Clinical Practice (ICH E6(R2)) (GCP) • Develop and deliver training on FDA GLP, OECD GLP, GCP regulations to the entire team • Lead quality accreditation and recognition initiatives for the company • Maintain company’s Standards Council of Canada recognition of compliance with OECD GLP • Host external inspections by sponsors, accrediting or certifying bodies, and regulatory agencies • Development and Maintenance of existing SOPs and writing new SOPs. Publish and control the standards, regulations and laws. • Maintain the list of SOPs and control the assignment of SOP, FRM, TEM codes. • Vendor/Supplier Audits • Validation of Computer Systems implemented at Immuni T • Provide, develop, source and coordinate ongoing regulatory and compliance presentations and associated training to the entire team to ensure that all colleagues understand and comply with FDA GLP, OECD GLP, GCP regulations and guidlines • Lead system validation studies and ensure that system validations are planned, conducted, and reported in compliance with the applicable standard operating procedures, policies, standards, regulations and laws • Work with process owners, system owners, users, and management • Ensure that validated systems maintain their validated state and Submit system validation documentation for archiving promptly to ensure that the documentation is protected from loss and untimely deterioration • Ensure data generated by validated systems is available for review throughout the required retention period for the material • Ensures that archive facilities and archived materials operate in compliance with the applicable standard operating procedures, policies, standards, regulations, and laws • Controls access to archived materials. Controls and documents the movement of materials in and out of the archives. Manages off-site archiving service providers, including ensuring that the providers meet their obligations under the applicable contract and / or service level agreement. Preferred Qualifications • B.Sc. or M.Sc. or Ph.D., with at least 5-7 years of experience in Quality Assurance • In-depth experience with FDA GLP, OECD GLP, GCP as applied to the audit of bioanalytical facilities • Experience hosting inspections by sponsors, accrediting or certifying bodies, and regulatory agencies • Familiarity with principles of operation of common bioanalytical equipment and instruments • Experience with Ligand Binding Assays (LBA) and Flowcytometry techniques is a must
Analyst
The role of an Analyst at Immuni T is to develop and implement classical and novel approaches for cell-based and non-cell based assays using flow cytometry, ELISpot. ELISA, MSD orLUMINEX platforms for example. He/she, has responsibility to serve as a technical resource and bench analyst in the lab. The Analyst will work to establish Standard Operating Procedures (SOPs) under Good Laboratory Practices (GLP). She/He is expected to understand and have hands-on expertise in standardization, validation and samples analysis for pre-clinical and clinical studies. Other responsibilities are, but not limited to: To carry out cell culture of primary immune cells, or cell lines, for the purpose of conducting cellular phenotyping and functional assays; To be able to use technology transferred assays (method transfers) sent by client sites and thus support cross-site standardization of analytical methods; Maintain proper documentation of all research activities in compliance with the relevant Standard Operating Procedures (SOPs), policies, and applicable regulations; To demonstrate continuous integrity and credibility; To develop new assays using various platforms including novel cell culture systems, ELISA, ELISpot, Luminex, MSD, Flow cytometry; To be able to document procedures execution, deviations, troubleshooting activities if needed; To perform in-depth data analysis for each experiment and prepare data analysis packages, including text, tables and figures; To present data and work procedures internally to the team, and externally to the clients; To be able to team work and communicate effectively with other team members and responsible managers; Qualifications: Dec or B. Sc. in immunology, cell biology, molecular biology, or a related discipline; A minimum 1 year experience in a biotech/pharma or CRO companies is an asset; Hands-on experience in designing multicolor flow cytometry panels (up to few dozen color panels), cell purification and enrichment schemes (magnetic beads enrichment for example), qPCR, ELISA, multiplexed Luminex assays, multiplex in vitro cytotoxicity assays and other applicable techniques; Knowledge of non-flow cell-based assays to monitor innate and adaptative molecular and cellular response patterns; Excellent time management and good organizational skills and the ability to work effectively in a high paced, fast changing environment, on multiple projects through their ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; Strong troubleshooting skills; Able to work effectively independently as well as in a team; Knowledge and understanding of GLP, GCLP, regulations and other regulatory guidelines; Must be willing to perform duties in Bio Safety Level 2 (BSL-2) facilities; Excellent written and oral communications skills (English and French).