Conducts and manages regulated and non-regulated bioanalytical work, representing the sponsor as Bioanalytical Principal Investigator. Ensures the studies meet all the requirements of the study protocol, SOPs, and appropriate regulations. The Bioanalytical Principal Investigator ensures the scientific integrity of the study documentation, data, and reports, and ensures they are in compliance with appropriate regulations via quality processes as they pertain to the conduct of bioanalytical studies.
- Regulatory and scientific oversight of regulated bioanalytical studies.
- Analysis, interpretation, and approval of study data.
- Primary point of contact for Sponsor and/or Study Director
- Preparation and review of Validation and Sample Analysis Plans
- Preparation and creation of analytical batches, data reduction, data review and preparation of final analytical reports that are written according to SOPs and ready for QC/QAU review.
- Maintain metrics to track workflow. Assist in the development and maintenance of review schedules and functional area metrics as applicable.
- Coordinates with Lab Management, Method Development/Validation, QC, QA and Reagent Groups to ensure adequate resources are available for proper execution of the assay schedule.
- Scheduling and coordination with QAU of audit events, including in-process audits address and correct issues arising from quality assurance audits promptly, with corrective actions.
- Sponsor interactions including maintenance of meeting minutes, critical Sponsor communication documentation and timely transfer of data and records.
- At least 4-6 years’ hands-on experience (CRO or Pharmaceutical) in large molecule immunoassay development/validation.
- Experience working in GxP environment and knowledge of applicable GLP and GCP regulations and bioanalytical guidelines
- Knowledge of industry practices for bioanalytical analysis and applicable software used to support bioanalytical work
- Good verbal, written, and organizational skills are required
If interested, please send CV to Info@immunologixlabs.com.