Director, Analytical Outsourcing & Stability, Biologics Biopharmaceutical Development

About the role

Eisai’s human health care (hhc) mission focuses on satisfying unmet medical needs and increasing the benefits of healthcare for patients, families, and caregivers. As a growing pharmaceutical company breaking through in neurology and oncology, Eisai seeks highly‑motivated individuals to work in a fast‑paced environment. The Director, Analytical Outsourcing & Stability will oversee product release and stability testing at U.S. and international sites, serve as a scientific and technical resource for early‑ to late‑stage manufacturing programs, and manage analytical testing for multiple biologic products.

Responsibilities

• Manage external testing laboratory collaborations.
• Review and interpret analytical testing data, protocols, and reports with emphasis on scientific validity and regulatory compliance (FDA, EMEA, ICH, JP).
• Troubleshoot analytical assays and design future studies.
• Oversee assay validation activities and technology transfer to contract manufacturing organizations (CMOs).
• Interact with quality assurance to determine product stability and shelf life.
• Interface with internal and external clients, suppliers, and contractors.
• Ensure projects remain on schedule and within budget; identify major milestones and critical steps.
• Communicate progress, potential impediments, and solutions to team members and management.
• Track finances and accounting for multiple drug development programs.
• Additional projects and responsibilities may be assigned at the company’s discretion.

Requirements

• Graduate‑level degree in biological sciences or a related field; Ph.D. highly preferred.
• Minimum 8 years of relevant analytical experience with biologics development, including several years in a management role.
• Strong knowledge of biologics manufacturing and analytical methodology, and familiarity with ICH, cGMP, EMEA, and JP guidelines for monoclonal antibodies, ADCs, bispecifics, and fusion proteins.
• Prior contract manufacturing project‑management experience preferred.
• Experience with biologics development from pre‑IND through Phase 3 or commercial production.
• Understanding of project accounting and financial concepts; participation in budgeting, tracking, and financial decision‑making.
• Hands‑on, proactive approach with excellent interpersonal, analytical problem‑solving, and priority‑setting skills.
• Strategic thinking, energy, enthusiasm, and an entrepreneurial mindset.
• Willingness and ability to travel domestically and internationally approximately 20 % of the time.

Pay

Annual base salary range: $202,800 – $266,200. This position is eligible to participate in the Eisai Inc. Annual Incentive Plan and Long‑Term Incentive Plan. Final compensation will depend on experience, education, knowledge, and skills.

Benefits

Employees are eligible to participate in Eisai’s employee benefit programs. Additional benefits may be available for this position; please discuss any questions with your recruiter. For more information on the benefit programs, visit the Eisai benefits page.