We are seeking to add an Associate Director / Director to our fast growing Immunoassay Laboratory.
Senior Level Scientist to manage large molecule bioanalytical laboratory operations and lead lab team in the development, validation, and implementation of immunoassays in support of pre-clinical and clinical studies.
- Provide scientific and technical expertise to develop and validate PK, Biomarker, Immunogenicity and Neutralizing antibody immunoassays (ELISA, MSD, etc.).
- Lead laboratory team and oversee daily laboratory operations pertaining to assay development, validation, sample analysis activities.
- Troubleshoot assays and procedures and advise team members, as needed.
- Manage lab operations, including hands-on training, review of study data, and other applicable bioanalytical lab functions.
- Oversee the generation of bioanalytical study documents including assay development summaries and test methods.
- Interact with QA to ensure lab operations (e.g. equipment qualification/maintenance, personnel training, SOPs and controlled forms, documentation and recordkeeping, archiving) are in compliance with applicable GLP/GCP regulations, guidances and Immunologix SOPs.
- Interact with management and clients in planning new projects and test procedures.
- Participate in client visits and audits, as needed.
- Attend and present at scientific conferences.
- At least 10 years’ experience in regulated environment, CRO, biotech or pharmaceutical company.
- Hands-on/supervisory experience on immunoassay development, validation, sample analysis.
- Knowledge of applicable GLP and GCP regulations and bioanalytical guidelines
- Experience with Watson LIMS, Microsoft products
- Must be able to multi-task in a dynamic working environment.
- Good verbal and written communications skills a must-have.
If interested, please send CV to Info@immunologixlabs.com.