Assay Validation Specialist
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 an Assay Validation Specialist for its flow cytometry and serology platforms, for its site in Gosselies, Belgium.
Assay Validation Specialist
Reporting to the Laboratory Manager and working closely with the Principal Scientists, laboratory personnel, the Quality Assurance department and Management, the Assay Validation Specialist will oversee assay validations primarily in flow cytometry. As needed, this position may also be required to support the validation of other cell-based assays (e.g. ELISpot, neutralization assays) and serological assays (e.g. ELISA, MSD, Luminex).
- In close collaboration with Principal Scientists and Management, defining the optimal fit-for-purpose validation strategy for specific analytical services, with a focus on flow cytometry assays;
- Acting as a key resource to support the Principal Scientists for the writing of method SOP, validation plans and reports;
- Reviewing method SOP, validation plans and reports;
- Coordinating with Principal Scientists and Management to ensure progress of validation projects according to the validation plans;
- Working in close collaboration with the laboratory team to ensure that the validation experiments are properly documented and controlled;
- Ensuring that all documents associated with assay run are QC verified and approved by principal scientist;
- Ensuring that all validation documentation is generated timely, is complete, accurate and appropriately filed;
- Ensuring that all deviations/CAPA are documented timely, that impact assessment is performed and that the principal scientist finalizes the deviation timely.
- Generating and/or reviewing deviations and CAPA;
- Acting as a key resource to provide guidance and support in root cause analysis and impact assessment;
- Communicating with Principal Scientists and Management on project timelines, status, reports and any issue that may arise to ensure rapid resolution
- Participating in answering Quality Assurance reports resulting from an audit (raw data, in-life inspection, facility inspection).
Profile of the applicant:
The applicant must hold a minimum of a Master’s degree in life science, with at least 5 years of experience in the validation of bioanalytical assays performed in a regulated environment (biopharmaceutical or CRO industry).
The applicant must :
- Have excellent knowledge of flow cytometry assay development. Experience in the development of ELISA, MSD, Luminex and/or ELISpot assays is a strong asset.
- Be familiar with fit-for-purpose validation approaches and general validation guidelines (e.g. EMA, FDA, ICH Q2, …).
- Have strong knowledge of validation parameters to be performed for the different types of assays (flow cytometry, ELISPOT and ELISA).
- Be knowledgeable in the testing design for the various validation parameters, including knowledge of the acceptance criteria associated with the various validation parameters.
- Be knowledgeable in the conduct of assay validation with respect to documentation and QC verification.
- Have in-depth knowledge of Good Laboratory Practices and Good Documentation Practices and have a proven record for working in a solid GLP environment.
- Demonstrate excellent communication and organisational skills.
- Be fluent in English (written & spoken). Ability to functionally communicate in French is an asset.
- Full time permanent contract.
- Diversified tasks and responsibilities and interesting projects.
- A professional, dynamic and stimulating work environment.
- Development opportunities.
- A competitive salary package including benefits, adapted to your experience and the context.
Please, send your CV along with a brief introduction letter via our website: http://www.pahrtners.be/job/assay-validation-specialist/ or to email@example.com.
Your application and any information will be treated confidentially.