Associate Director, Biologics Operations Upstream & Downstream, Biopharmaceutical Development

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production processes for new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific leadership and oversight and managing individual performance and cost center budgets. The individual recruits staff as necessary and mentors, coaches, and develops staff to maximize individual potential and to grow and retain scientific talent.



The Associate Director is primarily responsible for the operation and efficiency of upstream and downstream production suites in a cGMP biopharmaceutical pilot plant, including scheduling of staff, preparation and close-out of documentation, manufacture of DS/ADI materials, and suite change-over ensuring compliance to relevant regulations. The Associate Director is also responsible to ensure successful scale-up and technology transfer of new production processes and technologies into the production suites.

The Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing supporting documentation. They formulate the overall strategy for Upstream and Downstream Operations and will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.



The Associate Director of Biologics Operations maintains knowledge of established and emerging technologies, utilizes internal and external networks, and leverages prior relevant experience to create an effective and efficient organization that is recognized for successfully bringing operations, science, and engineering principles to bear on advancing Eisai’s biopharmaceutical programs.

Essential Functions

1. Oversee the operations of the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre-clinical and phase I to phase III clinical studies, including the development of long-range planning and weekly production schedules. Be responsible for the scheduling of staff and facility, preparation and close-out of documentation, and maintenance of the facility and equipment in a qualified/validated state.

2. Provide supervision of Upstream and Downstream production staff in the operation of equipment to support preclinical and phase I to III clinical trials. Supervise change-over activities. Be responsible for ensuring routine suite and equipment maintenance, calibration, and validation with appropriate internal departments are done correctly and effectively

3.  Sets priorities, develops annual and biennial objectives aligned with department and divisional objectives, creates and maintains annual operating and capital budgets, and creates staffing plans based on prescribed organizational structures.

4. Oversee the scale-up of new DS/ADI processes and technologies, working with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at the company’s discretion.

5. Lead and assist in troubleshooting upstream and downstream process, product, and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective and preventive actions.

6. Oversee and coordinate the preparation of bill of materials, batch records, SOPs, and close-out reports for Biologics Pilot Plant campaigns.  Support providing data for regulatory documents as required.

7. Ensure adherence of operations to cGMP, ICH, EMEA, and JP Guidelines as well as industry safety standards and OSHA guidelines. Participates in biotechnology industry forums to acquire knowledge on industry best practices and emerging trends.