Associate Director, Biologics Operations Upstream & Downstream

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.

8. Oversee design, implementation, and commissioning of new technologies for manufacturing. Oversight of other areas within the facility may be added at the company’s discretion.

9. Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control, Validation, and other internal (PST) and external functions to support successful product development, including sharing expertise, ensuring optimum decision-making, facilitating smooth information exchange, and driving progress in biopharmaceutical programs.

10. Recruit, train, and develop staff. Ensure staff are trained in process-specific knowledge, equipment operation, and relevant regulations.

Scope Measures

The individual will play a critical role in the operation of the biologics pilot plant (whose purpose is to produce material for toxicology and phase I to III studies), and in the late-stage processes at CMOs that support the company’s clinical development pipeline. The individual contributes to the success of the organization by providing seasoned organizational leadership and deep scientific, engineering, and operations knowledge. Specifically, this person will contribute to the success of the operation by ensuring the development, optimization, and characterization of validatable DS/ADI production processes.

The individual leads groups of scientists and engineers, monitors multiple multifaceted development projects, ensuring high productivity and smooth operation of the Upstream and Downstream Operations groups. The individual will also ensure that the upstream and downstream suites, equipment, staff and infrastructure can support manufacture of materials for global clinical supplies. Finally, the individual will be responsible to maintain and/or enhance the production area systems and technology to remain compliant with regulations and to ensure the successful transfer of new products in development.

Requirements

• Education: BS, MS or PhD in biological sciences or engineering

• Ph.D. with 8 yrs., MS with 12 yrs., or BS with 15 yrs. of practical scientific experience

• Minimum of 8 yrs. in a multi-discipline cGMP environment, commissioning and managing biologics production areas.

• Knowledgeable in mammalian cell culture, microbial fermentation, purification, biologics equipment operation, and CIP/SIP operations.

• Knowledgeable in process development, technology transfer, equipment scale-up, equipment validation, and facility startup.

• Ability to identify, investigate, and solve process and equipment problems.

• Strong working knowledge of cGMP, EMEA, and JP regulations.

• Excellent written and communication skills.

• Excellent interpersonal skills.

• Team player who can excel in a “hands-on” entrepreneurial environment.

• Ability to supervise, mentor, train, and develop staff.

#LI-CC

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Right To Work

E-Verify Participation

R3709