3408

Director, Biologics

Director, Biologics

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.

Requirements:

  • 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.

 

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