Assay Validation Specialist
Caprion Biosciences is a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium). Caprion Biosciences offers analytical services to biopharmaceutical companies for the characterization of the human immune response in pre-clinical and clinical samples.
Caprion Biosciences operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotech companies.
In the context of its growing immune monitoring service offering in Gosselies (Belgium), we are looking for an (m/f):
Assay Validation Specialist
Reporting to the Laboratory Manager and working in close collaboration with the other services, you oversee assay validations primarily in flow cytometry. As needed, you also support the validation of ELISpot and ELISA assays.
Your main responsibilities include:
- Contribute to the definition of the optimal fit-for-purpose validation strategy for specific analytical services, with a focus on flow cytometry assays.
- Review and support the writing of method SOP, validation plans and reports.
- Ensure progress of validation projects according to the validation plans.
- Ensure that all documents associated with assay run are QC verified and approved by Principal Scientist.
- Generate and/or review deviations and CAPA.
- Provide guidance and support in root cause analysis and impact assessment.
- Ensure that all validation documentation is generated timely, is complete, accurate and appropriately filed.
- Participate in answering QA reports resulting from an audit.
- Communicate and report on project timelines, status and any issue that may arise.
- You hold a Bachelor’s or a Master’s degree in Life Science.
- You have 5 years of experience in a (bio)pharmaceutical or CRO industry, and at least 2 years of experience in the validation of bioanalytical assays.
- You have excellent knowledge in the development of ELISA and/or ELISpot assays. Experience in flow cytometry assay development is a strong asset.
- You are familiar with fit-for-purpose validation approaches and general validation guidelines.
- You have strong knowledge of validation parameters for the different types of assays.
- You are knowledgeable in the testing design for the various validation parameters, and in the conduct of assay validation with respect to documentation and QC verification.
- You have in-depth knowledge of GLP and GDP.
- You demonstrate excellent communication and organisational skills.
- You are fluent in English (written and spoken). Ability to functionally communicate in French is an asset.
- A full time permanent position with development opportunities.
- A professional, dynamic and stimulating international work environment.
- The opportunity to take part in diversified tasks and responsibilities and interesting projects.
- A competitive salary package including benefits, adapted to your experience and the context.
Please send your CV together with an adapted cover letter via http://www.pahrtners.be/job/assay-validation-specialist/ or to firstname.lastname@example.org.
Your application and related information will remain strictly confidential.
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