Manufacturing Tech II
Eisai US
Summary
The Manufacturing Technician II supports the manufacture of Commercial Gliadel wafers, including execution of approved SOPs and batch records to produce a quality product according to GMP guidelines. Takes responsibility for manufacturing, packaging, and labeling of a quality product in accordance with FDA, EU and JP Good Manufacturing Practices (GMP). Additional duties include performing equipment cleaning and maintenance per approved procedures, reviewing and revising documentation, and supporting protocol execution and EHS programs as assigned.
Job description
Essential Functions
Product Manufacturing / GMP Compliance
- Manufactures, packages, and labels product according to SOPs and Batch Record instructions and takes responsibility for manufacturing a quality product.
- Produce polymer materials through controlled chemical synthesis methods.
- Performs set-up, dismantling and maintenance of equipment and ensures equipment is ready for production operations.
- Completes cleaning of equipment/glassware according to SOPs.
- Weighs chemicals accurately.
- Participates in all processes of manufacturing, packaging, and labeling.
- Prepares solutions for production area cleaning and performs routine cleaning of areas.
- Conducts manufacturing activities to protect themselves, others, and company assets.
- Complies with SOPs, Batch Records, and other GMP documentation.
- Reviews work of self and others to ensure accuracy and compliance with good documentation practices.
- Completes & reviews batch records ensuring the accuracy of the document prior to review by management.
- Reports any compliance issues to Manufacturing leadership.
Process Improvement / Documentation Management
- Reviews and edits SOPs, batch records, and other documentation.
- Ensures that routine audits are completed accurately and in a timely manner.
- Edits qualification protocols for new and/or existing equipment or systems.
- Identifies process improvement opportunities and offers suggestions.
- Participates in trending of processes and/or processing parameters and provide initial evaluation of the data – notifying Manufacturing leadership of trends.
- Participates in execution of protocols & experiments to resolve issues and find solutions.
- Recommends scheduling or other efficiency improvements as indicated.
Equipment Maintenance / Troubleshooting
- Performs equipment maintenance such as periodic equipment cleaning, inspection, and filter changes, etc.
- Troubleshoots equipment as necessary during production operations.
- Maintains inventory of equipment and supplies and ensures the availability for production activities.
EHS Programs
- Supports the Hazardous Waste Program as a Hazardous Waste Coordinator.
- Performs monthly safety audits.
Training / Personal Development
- Completes annual GMP & safety training.
- Participates in on-going training.
- Assists in training new and existing employees.
- Continues SOP training as it pertains to daily tasks & participates in on the job training.
- Develops new skills and knowledge which are beneficial to self and organization.
- Cross trains to support other departments.
Requirements
- 2-4 year college education in Chemistry or other scientific discipline preferred
- A minimum of 1.5 years of work experience in a GMP environment preferred
- Experience with GMP commercial product manufacturing
- Packaging and labeling experience desired, but not required
- Knowledge of US and EU GMP regulations
- Working knowledge of MS Word, Excel and Outlook a plus
- Incumbent must be able to lift up to 50 lbs., stand for long periods of time, stoop or bend if necessary and operate manufacturing equipment
Benefits
- Annual Incentive Plan
- Company employee benefit programs
Company overview
Eisai US is the American pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., a global pharmaceutical company founded in 1941. Headquartered in Nutley, New Jersey, Eisai US operates with a passionate commitment to patient care through its human health care (hhc) philosophy, which places patients and their families at the forefront of all business decisions. The company focuses on two primary therapeutic areas: oncology and neurology, with particular emphasis on dementia-related diseases and neurodegenerative disorders. Eisai US maintains a fully integrated pharmaceutical business model with end-to-end capabilities spanning discovery, development, and marketing. The organization operates commercial and clinical development organizations in New Jersey, discovery labs in Massachusetts and Pennsylvania, and global demand chain operations in Maryland and North Carolina. Notable products in its portfolio include Leqembi (lecanemab) for Alzheimer's disease, Lenvima (lenvatinib) for various cancers, and Aricept (donepezil) for Alzheimer's treatment. With approximately 1,001-5,000 employees in the United States, Eisai US represents a significant presence in the American pharmaceutical landscape, dedicated to addressing unmet medical needs through innovative therapies and comprehensive patient support programs.