Exton, PA (Corporate)
- 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.
- 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.