Lead Research Assistant in Assay Validation
2 jours restants
- Temps de travail
- Temps plein
Caprion Biosciences, a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium), offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical samples.
Caprion operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotechs.
In the context of its growing immune monitoring service offering, Caprion is looking to hire a Lead Research Assistant in Assay Validation for its flow cytometry and serology platforms, for its site in Gosselies, Belgium.
Lead Research Assistant in Assay Validation
Reporting to the Laboratory Manager and working closely with Principal Scientists, the Lead Research Assistant in Assay Validation will work within a team focusing on the characterization of the cellular (ELISPOT and various flow cytometry assays such as immune-phenotyping, detection of intra-cellular cytokines, etc) and of the humoral (ELISA, Luminex, viral neutralization tests, etc) immune response.
Tasks include :
- Perform immunoassays according to current standard operating procedures and in accordance with regulatory requirements;
- Act as a leader in the laboratory for the development and qualification/validation of complex methods;
- Participate to the writing and/or to the review of method SOP, validation plans and reports;
- Work with the Principal Scientist to prepare experimental plans and worksheets needed for the conduct of validation studies;
- Participate to the identification critical technical steps executed in the laboratory for the success of validation studies;
- Ensure that all laboratory documents are self-verified, QC verified and approved by the Principal Scientist;
- Ensure that all deviations/CAPA are documented in a timely manner;
- Participate in experiment planning and problem solving;
- Participate to the technical management of the laboratory;
- Perform work according to internal quality standards, apply relevant Quality System procedures and participate to the continuous improvement of Quality documents.
- Attend relevant internal training activities.
Profile of the applicant :
The applicant must hold a bachelor’s or a master’s degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology and a minimum of 3 years of relevant laboratory experience in a regulated environment (biopharmaceutical or CRO industry). Theoretical and practical knowledge of techniques related to cellular and humoral immunology is required. Experience in flow cytometry assays and cell culture is a strong asset.
The applicant must :
- Be familiar with fit-for-purpose validation approaches and general validation guidelines (e.g. EMA, FDA, ICH Q2, …).
- Be familiar with the practical implementation of various validation parameters.
- Be knowledgeable in the conduct of assay validation with respect to documentation and laboratory practices.
- Demonstrate excellent organisational skills.
- Be detail-oriented.
- Demonstrate schedule adaptability and flexibility.
- Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes.
- Demonstrate ability to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP).
- Be functional in French (spoken and written) and have a functional knowledge of written English. Knowledge of spoken English is an asset.
- Full time permanent contract, with possibility of rapid start.
- Diversified tasks and responsibilities and interesting projects.
- A professional, dynamic and stimulating work environment.
- Training and development opportunities.
- A competitive salary package including benefits, adapted to your experience and the context.
Please, send your CV along with a short introduction letter via our website:
http://www.pahrtners.be/job/lead-research-assistant-flow-cytometry-serology/ or to email@example.com
Your application and any information will be treated confidentially.
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