Process Associate, Support Operations, Biologics Operations

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

Under supervision and guidance, the Process Associate I will be responsible for hand-on executing the routine operation and periodically commissioning/startup of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant. In addition, the individual will execute the process development and technology transfer studies in laboratory, document in the laboratory notebook, perform data interpretation, and summarize the study outcomes in presentations and/or technical reports. Furthermore, the individual will execute and participate in the activities for scale-up and system operations supporting the manufacture of preclinical, phase I, and phase II clinical materials, including assisting in the transfer of new technologies/processes, operation, and troubleshooting of cell culture bioreactors and harvest equipment, preparation and close-out of documentation, manufacture of materials, and ensuring compliance to relevant regulations. The Process Associate I will also assist by executing the implementation of process improvement strategies and evaluation of new technologies. The individual may also participate in a task sub team supporting a campaign and may provide cross-functional support for other departments within the pilot plant at the discretion of management.

Essential Functions

• Provide knowledge in cell culture and harvest operations/systems and work in a hands-on capacity in the operation of equipment for the manufacture of preclinical, phase I and phase II 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. 35%
• Provide hand-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. 35%
• Participate and contribute in the validation maintenance, re-qualification, and improvement of production equipment. Assist and contribute in the design, implementation, and commissioning of new technologies for manufacturing. Participation in other areas within the facility may be added at the company's discretion. 10%
• Assist and contribute in the preparation of bill of materials, batch records, SOPs, and close-out reports for each campaign. 5%
• Assist in troubleshooting product and equipment issues and deviations. 5%
• Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines. 5%
• Interact cross-functionally with Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful product development. 5%

Requirements

• BS in (Bio) Chemical Engineering or Engineering or Biological Sciences is a must.
• Minimum of 0-2 year practical scientific experience.
• Basic skills in designing and executing studies and interpreting data of technology transfer, scale-up, equipment validation studies.
• 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 large scale stir tank and/or single-use disposable bioreactors, centrifuge, micro-filtration, and CIP/SIP operations is a plus.
• Previous exposures to cGMP, EMEA, and JP regulations as a plus.

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.

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