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
L’analyste médical est responsable du traitement des spécimens biologiques pour fins de diagnostic dans le laboratoire d’hématologie. Il s’assure de l’intégrité des échantillons en suivant les normes et procédures établies : Effectuer les analyses des échantillons biologiques; Vérifier l’intégrité des spécimens afin d’en assurer une bonne gestion; Assurer la qualité des résultats en appliquant les différentes procédures normatives en vigueur; Toute autre tâche connexe requise par les fonctions du poste. Lieu et horaire de travail Immuni T est localisée dans le sympathique Quartier des spectacles avec un accès direct au Métro Place des arts, au complexe Desjardins et aux boutiques de la rue Sainte-Catherine. Siège social : Immuni T 5ème étage, bureau SB-5180 141 Avenue Président-Kennedy Montréal QC, H2X 1Y4 514 545 3097 UQAM campus et Quartier des spectacles. (Métro place des Arts) Horaire de travail Lundi au vendredi : 8h30 à 17h00 Le profil recherché Diplôme d’études collégiales en technologie d’analyses biomédicales ou technique de laboratoire médical; Être membre de OPTMQ Expérience pertinente en Immunologie et hématologie, un atout important; Maîtrise des logiciels de la suite Microsoft Office; Détenir un haut niveau d’autonomie; Être orienté vers le service à la clientèle. Contrôle de qualité Assure l'entretien préventif des appareils et la désinfection des surfaces de travail selon les procédures établies. Applique les procédures de contrôle de qualité des équipements et avise le coordonnateur du laboratoire en cas d’anomalies. Conserve les échantillons et les requêtes selon les procédures établies. Procède à l’élimination des échantillons, des requêtes et des déchets biomédicaux selon les procédures. Transmet les résultats d’analyses selon les procédures, en respectant les normes de confidentialité. Qualités personnelles et professionnelles • Esprit d’équipe et collaboration; • Communications interpersonnelles et organisationnelles; • Autonomie et rigueur; • Analyse et résolution de problème; • Crédibilité; • Sens de l’organisation; • Habiletés à gérer la charge du travail. Type d'emploi : Temps complet Langue: Française (Requis) Anglaise (Souhaité)
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).
The role of a Scientist at Immuni T is to develop, validate and implement novel approaches for cell-based and non-cell based assays in Immunology using flow cytometry, ELISpot. ELISA, MSD or LUMINEX platforms. He/she, has responsibility to serve as a scientific and technical resource to the study directors and the bench analysts. The Scientist will work to establish and maintain, with the team, Standard Operating Procedures (SOPs) under Good Laboratory Practices (GLP). She/He is expected to understand and have hands-on expertise in standardization, development, validation and samples analysis for discovery, development, pre-clinical and clinical studies. Other responsibilities include but are not limited to: 1. Set up and execute cell-based and in-vitro assays to assess the potential efficacy and safety of lead product candidates. 2. Carry out cell culture of primary immune cells or cell lines for the purpose of conducting cellular phenotyping and functional assays; 3. Lead technology transfer of assays to or from client sites and support cross-site standardization of analytical methods; 4. Support efforts to establish and maintain policies and procedures related to lab operations and biosafety. 5. Maintain electronic laboratory notebooks for proper documentation of all research activities in compliance with the relevant Standard Operating Procedures (SOPs), policies, and applicable regulations; 6. Ensure all projects assigned to him/her are performed on a timely basis, in a compliant manner and delivered with maximum impact, within specified budgets; 7. Deliver reports, summaries, and presentations supporting experimental results; 8. Demonstrate continuous integrity, credibility, positivity and motivational behaviour; 9. Develop new assays using various platforms including ELISA, ELISpot, Luminex, MSD and Flow cytometry; 10. Communicate with team members, upper managements and clients proactively; 11. Design, execute and document troubleshooting activities; 12. Interpret data in a scientific and professional manner and present it internally to the team, and externally to the clients. Qualifications: 1. M. Sc. or Ph.D. in immunology or equivalent experience in immunology using cell biology and molecular biology as tools; 2.A minimum 5 years experience in a biotech/pharma or CRO companies with experience developing, qualifying and validating assays for therapeutic programs; 3.Knowledge and understanding of GLP, GCLP regulations and other relevant regulatory guidelines;4. Hands-on experience in designing multicolor flow cytometry panels (up to few dozen color panels), cell culture, cell purification and enrichment schemes (magnetic beads enrichment for example), qPCR, ELISA, ELISpot , multiplexed Luminex assays for multiplexed in vitro cytotoxicity techniques; 5.Knowledge of non-flow cell-based assays to monitor innate and adaptative molecular and cellular response patterns; 6. Able to keep confidentiality of projects and possess high level of integrity; 7. 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; 8. Able to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. 9. Strong troubleshooting skills; 10. Able to work independently and in a team; 11. Must be willing to perform duties or supervise activities in Bio Safety Level 2 (BSL-2) facilities; 12. Communicates clearly and confidently and has excellent interpersonal and teaching skills; 13. Excellent written and oral communications skills (English and French)