Exton, PA (Corporate)
Job Duties and Responsibilities:
- Lead a group of scientists for Biomarker method development, validation and sample analysis in the regulated environment (GLP or CLIA).
- Manage all the biomarker projects on daily basis to ensure the quality, timeline and deliverable are met for each project.
- Provide strong technical support to the team on different biomarker platforms. Ability to trouble-shoot and solve technical and instrumental issues.
- Review bioanalytical documentation that includes study protocols, analysis plans, data packages, validation study reports and sample analysis reports.
- Act as the main point of contact for biomarker projects, discuss the projects with clients, and provide timely communication and updates internally and externally.
- Train staff on laboratory procedures, documentation and GLP / CLIA compliance.
- Write and update SOPs. Maintain GLP and CLIA compliant biomarker Labs.
- Provide technical support to Frontage biomarker Lab in China when needed.
- Support Business Development including reviewing proposals and meeting with new clients.
- PhD in Biology or Chemistry, or related field with experience managing a group of scientists
- Hands-on experience in ligand binding assays, biomarker analysis and instrumentation such as MSD, Simoa, Luminex, etc.
- Strong experience and knowledge of method development / validation for supporting regulated studies
- Excellent communication and interpersonal skills and project management skills.