Director, Biologics Analytical Outsourcing & Stability

Eisai US; United States; Sur place; USD 203 000 - 266 000; Plein temps

Résumé du poste

Eisai Inc. in the United States seeks a Director, Analytical Outsourcing & Stability to oversee product release and stability testing at US and international sites.

You will review analytical data, troubleshoot assays, and support early to late-stage programs with strong regulatory knowledge (FDA, EMEA, ICH, JP). The role requires 8+ years in biologics analytics, PhD preferred, with experience managing budgets and cross-functional teams.

Qualifications

• Ph.D. is highly preferred; graduate degree in biological sciences.
• 8+ years of analytical experience in biologics development with hands-on leadership.
• Strong knowledge of biologics manufacturing and analytical methods.
• Experience with cGMP, ICH, EMEA and JP guidelines across development stages.
• Prior contract manufacturing project management experience is desirable.
• Ability to manage budgets and financial decisions for multiple programs.

Responsabilités

• Oversee external testing lab collaborations and data interpretation.
• Troubleshoot assays and design future studies; manage assay transfer to CMO.
• Lead assay validation activities and coordinate with QA to ensure compliance.
• Manage project budgets, milestones and timelines across US and international sites.
• Communicate progress and risks to management and stakeholders.

Connaissances

Project management

Biologics knowledge

Analytical testing

Leadership experience

Interpersonal skills

Financial acumen

Travel willingness

Formation

Ph.D. in Biological Sciences

Description du poste

Eisai Inc. in the United States seeks a Director, Analytical Outsourcing & Stability to oversee product release and stability testing at US and international sites.

You will review analytical data, troubleshoot assays, and support early to late-stage programs with strong regulatory knowledge (FDA, EMEA, ICH, JP). The role requires 8+ years in biologics analytics, PhD preferred, with experience managing budgets and cross-functional teams.