Senior Manufacturing Technician, Biologics Operations Upstream and Downstream

Employer
Eisai Inc.
Location
Exton, PA
Salary
Competitive
Posted
Jun 21, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

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. Manufacturing Technician will be responsible for the performance of all critical biologics manufacturing steps per production scheduling, material staging, equipment set-up, and GMP operations in the Biologics Operations group. The Sr. Manufacturing Technician will execute the routine operation of aseptic inoculum, bioreactor, purification, and formulation equipment of upstream and downstream process steps, monitoring the process performance, assisting troubleshooting, and adhering to GMP documentation and ensuring compliance to relevant regulations.

 

Essential Functions

  • Provide hands-on support and/or some leadership in the operation of equipment to support commercial manufacturing.  Coordinate equipment maintenance, calibration, and validation with appropriate internal departments.
  • Perform review and revision of SOPs and master batch record instructions to improve operational accuracy and efficiency.
  • Execute SAP transactions in a commercial environment.
  • Support in troubleshooting product and equipment issues and deviations.   Lead / assist in providing timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.
  • Interact cross-functionally with Support Operations, Facilities, R&D, Quality Assurance, Quality Control, Validation, and other internal and external functions to support successful commercial manufacturing campaigns.
  • Ensure adherence of operations to cGMP, ICH, EMA and JP Guidelines as well as industry safety standards and OSHA guidelines.

 

Requirements

  • Minimum of 7 years’ experience in upstream (cell culture) and/or downstream (purification and formulation) operations at a pharmaceutical or biotechnology company
  • Proficient in the operation of all area specific production equipment such as BSC, CO2 incubator, bioreactor, SIP, CIP, AKTA skid, UF/DF skid, and chromatography column packing.
  • End-User experience and/or knowledge in SAP Process systems as used in a regulated manufacturing environment (not IT SAP role)
  • Ability to identify, investigate, and resolve basic process and equipment problems.
  • Strong working knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
  • Ability for weekend rotation and few long process days.
  • Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Biologics Operations.
  • Self-starter with a strong focus on detail, safety, quality and results.
  • Strong written and verbal communication skills.

 

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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