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.

Essential Functions:

*Provide knowledge in downstream purification and formulation equipment operations/systems and work in a hands-on capacity in the operation for the manufacture of preclinical and clinical trial materials. Assist in the coordination of equipment maintenance, calibration, and validation with appropriate internal departments. Support process performance monitoring, operational excellence activities, and assist in the implementation of process improvement strategies. Provide cross-functional support for other departments within the pilot plant at the discretion of management.

*Provide hands-on execution for the process development, technology transfer, and scale-up of new processes and technologies working with R&D personnel. Document in the laboratory notebook, perform data interpretation, and summarize the study outcomes in presentations and/or technical reports.

*Contribute in the preparation of bill of materials, batch records, SOPs, and close-out reports for each campaign.

*Participate and contribute in the validation maintenance, re-qualification, and improvement of downstream (purification and formulation) production equipment.

*Assist and contribute in the implementation and commissioning of new technologies for downstream manufacturing. Participation in other areas within the facility may be added at the company's discretion.

*Assist in troubleshooting product and equipment issues and deviations.

*Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.

*Interact cross-functionally with Downstream Operations, Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development.

Scope Measures:

The individual will play a hands-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical and clinical biologics bulk drug substance to support Eisai's pipeline. Execution of manufacturing operations and compliant documentation of work within a GMP production setting is expected.

Specifically, this person will participate and contribute to the success of the downstream operation and purification processes for the manufacture of materials for global clinical supplies. The individual will also participate in monitoring and maintaining and/or enhancing the production area processes and technology to remain compliant to regulations. The individual may also participate in a task subteam supporting a campaign and may provide cross-functional support for other departments within the pilot plant at the discretion of management.

Requirements:

Education: BS in Biotechnology or (Bio)Chemical Engineering or Engineering or Biological Sciences is a must.

Experience:

*Minimum of 0-2 year (BS) practical scientific experience.

*Ability to follow direction, work under supervision, and demonstrate capability in organizing complex tasks within a cGMP production setting.

*Basic skills in executing routine production, maintenance, and operation of downstream equipment. Must have a mechanical aptitude.

*Good aseptic technique.

*Good written and communication skills.

*Good problem solving and interpersonal skills with the ability to work in a team environment required.

*Abilities to identify, investigate, and trouble-shoot basic process and equipment problems.

*Capabilities in the operation of all area-specific production equipment such as pilot and commercial scale chromatography columns and control skids, TFF systems and filtration technologies.

*Previous exposures to cGMP, EMEA, and JP regulations as a plus.

Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.

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:

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