Job Description:

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.

JOB SUMMARY

The Process Scientist or Process Engineer of Upstream Operations has strong knowledge, skills, and experiences in upstream production processes and equipment operations applicable to Eisai biopharmaceutical programs, and employee that qualifications to assure the upstream production is robust, effective, efficient and safe. The individual will provide significant technical expertise for upstream process transfer, scale-up, and systems supporting the manufacture of preclinical, phases I, II, and III clinical materials including leading in the transfer of new technologies/processes, operation and troubleshooting, preparation and close-out of documentation, planning of material and consumable logistics, manufacture of upstream clinical materials, and ensuring compliance to relevant regulations. The Process Scientist or Process Engineer will also lead or participate in the implementation of process improvement strategies, evaluation of new technologies, and procurement of capital investment. The individual may be assigned to lead a team supporting a campaign.

ESSENTIAL FUNCTIONS

* Provide leadership and/or hands-on execution in the operation of equipment to support preclinical, phases I, II, and III clinical trials. Coordinate equipment maintenance, calibration, and validation with appropriate internal departments.

* Provide prioritization, coordination, and collaboration strategies for the process development, technology transfer, and scale-up of new processes and technologies working with PD and the technology transfer laboratory personnel. Lead process performance monitoring, operational excellence activities, and process improvement strategies.

* Coordinate and participate in the validation maintenance, re-qualification, and improvement of upstream production equipment. Participate in the design, implementation, and commissioning of new technologies for upstream manufacturing.

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

* Lead in troubleshooting product and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing process non-conformances, corrective and preventive actions, change controls, and implementation activities.

* Ensure adherence of operations to cGMP, ICH, FDA, EMEA, JP, and ICH Guidelines as well as Quality by Design, industry safety standards, OSHA guidelines, and Quality Culture and Reduction of Human Error initiatives.

* Lead teams supporting a technology transfer and/or a campaign.

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

REQUIREMENTS

* Education: BS, MS or PhD in (Bio)Chemical Engineering or Engineering or Biological Sciences or equivalent job experience/degree is strongly preferred

* Experience:

* Minimum of 9-10 yrs (BS), 7-8 yrs (MS), or 3-4 yrs (PhD) practical scientific experience

* Minimum of 6 yrs in a multi-discipline cGMP environment, commissioning, and running equipment in upstream production areas.

* Knowledgeable in upstream process, equipment operation, and CIP/SIP operations.

* Knowledgeable in technology transfer, equipment validation, utilities, and facility.

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

* Strong working knowledge of cGMP, EMEA, and JP regulations and ICH guidelines.

* Excellent written and communication skills

* Excellent project planning and management skills.

* Excellent interpersonal skills.

* Team player who can excel in a hands-on entrepreneurial environment.

* Ability to mentor and train staff in scientific/engineering principles.

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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