3584

Director,PK-ADA, Biologics

Director,PK-ADA, Biologics

Exton, PA (Corporate)

Responsibilities:

  • Lead a group of scientists for PK/TK, immunogenicity (ADA, Nab) method development, validation and sample analysis in the regulated environment.
  • Manage all the projects within the Biologics Department on daily basis to ensure the quality, timeline and deliverable are met.
  • Provide strong technical support to the team on different assay formats. Ability to trouble-shoot and solve technical issues.
  • Review bioanalytical documentation that includes study protocols, method validation plan, sample analysis plans, data packages, validation study reports and sample analysis reports.
  • Act as the main point of contact for biologics projects, discuss the projects with clients, and provide timely communication and updates internally and externally.
  • Train staff on laboratory procedures, documentation and GLP compliance.
  • Write and update SOPs. Maintain GLP compliant PK and immunogenicity Labs.
  • Provide technical support to Frontage PK and immunogenicity Labs 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, especially PK and ADA method development.
  • Strong experience and knowledge of method development / validation for supporting regulated studies
  • Excellent communication and interpersonal skills and project management skills.

Apply Online