Director-PK / ADA-Biologics Services

Director / Sr. Director-Biologics (PK-ADA)

Location : Exton, PA

Full-time

Frontage Laboratories Inc. is an award winning, full-service, CRO / Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics / pharmacodynamics (PK / PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

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

Salary And Benefits

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance

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.