What are the responsibilities and job description for the Director-PK/ADA-Biologics Services position at Frontage Laboratories?
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.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
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