Director of Biologics Analytics Outsourcing & Stability

Eisai US; Exton, Northern (PA, KY); Hybrid; USD 203,000 - 266,000; Full time

Job summary

Eisai is seeking a Director of Analytical Outsourcing & Stability for Biologics Biopharmaceutical Development in Exton, PA. The role oversees analytical testing, stability programs, and tech transfers across US and international sites, while guiding projects from pre-IND through phase 3 and interacting with QA to ensure compliance with FDA, EMEA, ICH and JP guidelines.

The position requires a graduate degree in biological sciences (Ph.D.

Qualifications

• Graduate degree in biological sciences or related field; Ph.D. preferred.
• Minimum 8 years of analytical experience in biologics development.
• Strong knowledge of ICH, cGMP, EMEA and JP guidelines relevant to biologics development.

Responsibilities

• Manage external testing lab collaborations.
• Review and interpret analytical data.
• Troubleshoot analytical assays and design future studies.
• Manage assay tech transfer to CMO and assay validation activities.
• Review testing protocols and reports.
• Interact with QA and other departments to ensure compliance.
• Track finances and budgeting for multiple programs.

Skills

Leadership

Analytical experience

Regulatory knowledge

Project management

Budgeting knowledge

Education

Graduate degree in biological sciences

Ph.D. preferred

Job description

Eisai is seeking a Director of Analytical Outsourcing & Stability for Biologics Biopharmaceutical Development in Exton, PA. The role oversees analytical testing, stability programs, and tech transfers across US and international sites, while guiding projects from pre-IND through phase 3 and interacting with QA to ensure compliance with FDA, EMEA, ICH and JP guidelines.

The position requires a graduate degree in biological sciences (Ph.D.