At Eisai, our mission is to satisfy unmet medical needs and enhance the benefits healthcare provides to patients, their families, and caregivers. We are a growing pharmaceutical company making breakthroughs in neurology and oncology, with a strong focus on research and development. Our history includes the development of innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we seek highly motivated individuals eager to work in a fast-paced environment and make a difference.
Position: Sr. Manager, Exton Commercial BDS Manufacturing
Location: Exton, PA
The Sr. Manager is responsible for scheduling EDCS manufacturing personnel (including hourly staff) and overseeing daily execution of critical cGMP upstream and downstream processing steps, including process performance monitoring, material staging, equipment setup, maintenance, and cleaning/changeover for commercial drug substance (DS) or antibody drug intermediate (ADI) manufacturing in compliance with regulations. This role ensures that manufacturing processes, which impact safety, quality, identity, potency, and purity of DS or ADI, are conducted effectively and documented accurately. The manager supervises the EDCS Commercial Manufacturing team and collaborates with other Biologics Pilot Plant functions to ensure proper process execution.
Additional responsibilities include establishing objectives, conducting performance evaluations, managing timesheets, investigating deviations, and interacting with regulatory inspectors during inspections and audits. The role ensures compliance with US, EU, and JP regulatory guidelines, GMPs, SOPs, and EH&S standards.
Key Responsibilities:
1. Oversee execution of critical cGMP upstream and downstream processing steps, including schedule planning, documentation, process monitoring, material procurement, and equipment setup/maintenance.
2. Supervise manufacturing team members and coordinate batch record reconciliation activities.
3. Oversee SAP inventory transactions and QA record reviews.
4. Monitor, record, and analyze production metrics, and resolve deviations through CAPA.
5. Ensure all manufacturing activities adhere to regulatory, GMP, SOP, and EH&S guidelines.
Minimum Requirements:
* Eight (8) years of relevant manufacturing experience.
* Five (5) years of experience with documentation activities using eDOC, SAP, and LIMS, managing deviations, CAPAs, and change controls, and writing/revising SOPs and OJTs.
Application:
Send resumes to the HR Department, Job Code: R3671. Address: Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110.
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Equal Opportunity Statement:
Eisai is committed to equal opportunity employment and prohibits discrimination based on race, color, religion, gender, age, national origin, citizenship, marital status, sexual orientation, gender identity, disability, or veteran status. We also provide reasonable accommodations and participate in E-Verify to verify employment eligibility.
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