Sr. Manager, Exton BDS Commercial Manufacturing, EDCS
Apply NowCompany: Eisai
Location: Exton, PA 19341
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.
The Sr. Manager, Exton Commercial BDS Manufacturing is responsible for scheduling EDCS manufacturing personnel (including hourly staff) and overseeing day-to-day execution of all critical cGMP upstream and downstream processing steps including monitoring process performance, staging material, and performing equipment set-up/maintenance and cleaning/changeover for commercial drug substance (DS) or Antibody Drug Intermediate (ADI) manufacturing in compliance to regulations. Critical manufacturing processes have the potential to affect safety, quality, identity, potency and purity of DS or ADI. The Sr. Manager also ensures timely and accurate documentation creation, reviews batch record for release to Quality Assurance, and manages production schedule to meet company objectives.
The Sr. Manager supervises EDCS Commercial Manufacturing team and collaborating closely with other Biologics Pilot Plant functions (including MDC Preclinical/Clinical Production staff) in proper process execution using manufacturing techniques, equipment, and procedures.
The Sr. Manager is also responsible for establishment of objectives, performance evaluations, and timesheet management. Investigate and write deviation reports to support area of responsibility as needed. Interact with regulatory inspectors during inspections and audits. They ensure that manufacturing objectives are conducted according to regulatory guidelines (US, EU and JP), GMP's, SOP's, and EH&S guidelines.
Sr. Manager, Exton BDS Commercial Manufacturing, EDCS sought in Exton, PA. Oversee execution of critical cGMP upstream and downstream processing steps, including schedule planning, preparing and maintaining manufacturing document, monitoring process performance, procuring materials, and performing equipment set-up/maintenance and cleaning/changeover for commercial Drug Substance or Antibody Drug Intermediate manufacturing. Supervise EDCS Commercial Manufacturing team members. Coordinate batch record reconciliation activities. Oversee SAP inventory transactions and QA record reviews. Monitoring, recording, and trending of production metrics. Submit, analyze, and provide CAPA resolution for responsible area deviations. Ensure manufacturing objectives are conducted according to regulatory, GMP's, SOP's, and EH&S guidelines.
Requirements:
Eight (8) years of relevant experience working in a manufacturing environment. Also requires five (5) years of experience using/with the following (which may have been gained concurrently):
Please send resumes to HR Department, Job Code: R3671 Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110.
#LI-DNI
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:
Right To Work
E-Verify Participation
The Sr. Manager, Exton Commercial BDS Manufacturing is responsible for scheduling EDCS manufacturing personnel (including hourly staff) and overseeing day-to-day execution of all critical cGMP upstream and downstream processing steps including monitoring process performance, staging material, and performing equipment set-up/maintenance and cleaning/changeover for commercial drug substance (DS) or Antibody Drug Intermediate (ADI) manufacturing in compliance to regulations. Critical manufacturing processes have the potential to affect safety, quality, identity, potency and purity of DS or ADI. The Sr. Manager also ensures timely and accurate documentation creation, reviews batch record for release to Quality Assurance, and manages production schedule to meet company objectives.
The Sr. Manager supervises EDCS Commercial Manufacturing team and collaborating closely with other Biologics Pilot Plant functions (including MDC Preclinical/Clinical Production staff) in proper process execution using manufacturing techniques, equipment, and procedures.
The Sr. Manager is also responsible for establishment of objectives, performance evaluations, and timesheet management. Investigate and write deviation reports to support area of responsibility as needed. Interact with regulatory inspectors during inspections and audits. They ensure that manufacturing objectives are conducted according to regulatory guidelines (US, EU and JP), GMP's, SOP's, and EH&S guidelines.
Sr. Manager, Exton BDS Commercial Manufacturing, EDCS sought in Exton, PA. Oversee execution of critical cGMP upstream and downstream processing steps, including schedule planning, preparing and maintaining manufacturing document, monitoring process performance, procuring materials, and performing equipment set-up/maintenance and cleaning/changeover for commercial Drug Substance or Antibody Drug Intermediate manufacturing. Supervise EDCS Commercial Manufacturing team members. Coordinate batch record reconciliation activities. Oversee SAP inventory transactions and QA record reviews. Monitoring, recording, and trending of production metrics. Submit, analyze, and provide CAPA resolution for responsible area deviations. Ensure manufacturing objectives are conducted according to regulatory, GMP's, SOP's, and EH&S guidelines.
Requirements:
Eight (8) years of relevant experience working in a manufacturing environment. Also requires five (5) years of experience using/with the following (which may have been gained concurrently):
- Documentation activities with eDOC, SAP, and LIMS.
- Deviations, CAPAs and Change Controls through Master Control.
- Writing and revision of SOPs and OJTs.
Please send resumes to HR Department, Job Code: R3671 Eisai, Inc., 200 Metro Blvd, Nutley NJ 07110.
#LI-DNI
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:
Right To Work
E-Verify Participation