Regulated Bioanalyst

SUMMARY:
This position will participate with teams and research units in a Matrix environment. The person will demonstrate experience in the delivery of mass spectrometry based in animal and clinical studies, and have strong knowledge of bioanalytical methodologies as related to mass spectrometry platforms, sample extraction/isolation techniques, and chromatographic separation theory and application.

DUTIES:

- Responsible for developing partnerships in a Matrix environment, influencing project strategies, and providing expertise in technology development and implementation.
- This role will participate in all phases of regulatory laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
- Responsible for maintaining regulatory compliance appropriate for clinical and preclinical study execution including all proscribed training as found in SOPs and training transcripts. This includes knowledge, training and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting portfolio projects as applicable.
- Participate in continuous improvement of scientific and regulatory processes via update/creation of SOP's, design and implementation of laboratory and study based processes, and development of best practices for bioanalytical data generation.
- Responsible for QC and peer review of raw data, results, and final reports from other colleagues within the regulated group (depending on level of training).
- Additionally responsible for participation in internal and external audits providing required information to auditors as needed.
- May also participate/respond to internal audit findings on assigned projects.

SKILLS:

- Regulated LC/MS Bioanalysis skills
- Mass Spectrometry Expertise
- Chromatography, biological sample extraction
- Knowledge of GLP regulations