Develop PK and Immunogenicity immunoassay test methods with supervision. Validate immunoassay test methods and analyze bioanalytical samples per SOPs and test methods and report results to bioanalytical Principal Investigator.
- Work hands-on to develop and validate PK, Immunogenicity and Neutralizing antibody immunoassays (ELISA, MSD, etc.).
- Provide scientific expertise and oversight in assay development, validation and sample analysis.
- Troubleshoot problems and advise lab team, as needed.
- Oversee laboratory equipment use and maintenance.
- Review developmental, validation and sample data.
- Develop and write bioanalytical test methods as necessary.
- Operate laboratory equipment and perform routine maintenance as required.
- Prepare laboratory solutions, reagents, and bio-conjugated materials following standardized procedures.
- Accurately pipet and quantitatively transfer solutions and samples.
- Carefully follow laboratory instructions, procedures and methods.
- Conduct lab operations according to applicable SOPs, test methods and regulatory requirements.
- Follow good documentation practices; keep lab records in a consistent, compliant and accurate manner. Record documentation per appropriate formats (e.g. controlled form, notebook, logbook)
- Ensure routine maintenance, scheduled performance verification testing, documentation and training for assigned equipment is conducted as required per applicable SOPs.
- Assist in inventory maintenance, monitoring, ordering and receiving of lab materials.
- A minimum of 1 year hands-on experience (CRO or Pharmaceutical) in large molecule immunoassay development/validation.
- Experience as a Medical Technologist will be considered in lieu of pharmaceutical experience
- Knowledge of applicable GLP and GCP regulations and bioanalytical guidelines
- 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@bds.com.