Microbiologist II

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.

Essential Functions

• Conducts environmental monitoring sampling of manufacturing cleanroom areas and purified water systems with minimal supervision and direction to support the manufacture of commercial product.
  
• Supports the validation of manufacturing processes and equipment through environmental sampling and microbiological testing.
  
• Assists QC management in the oversight of microbiological testing performed by third party contract laboratories.
  
• Authors laboratory investigations for out of trend (OOT) and out of specification (OOS) results.
  
• Trains microbiology personnel on sampling techniques and procedures.
  
• Accurately records, summarizes, trends and reviews microbiology data in accordance with cGMPs and SOPs.
  
• Authors deviation reports, test methods, and SOPs.
  
• Maintains all instrumentation in a calibrated state.
  

Requirements

• BS/BA or MS in Microbiology or closely related field.
  
• 3+ years (BS/BA) or 1+ years (MS) of related experience in pharmaceutical industry.
  
• Demonstrated proficiency in microbiological techniques such as aseptic testing, microbial environmental monitoring, gram staining, plating and membrane filtration.
  
• Knowledge of cGMPs, USP testing and FDA regulations.
  

Other Skills/Abilities

• Experience working in aseptic/cleanroom environment.
  
• Knowledge of European Union (EU) and Japanese (JPN) cGMPs and regulations.
  
• Experience in microbiological techniques such as: subculturing, microbial ID testing, bacterial endotoxin testing, bioburden testing and sterility testing.
  
• Preferred candidates will also have:
  
  • Additional experience in leading investigations; as well as writing investigations, method validations and procedures.
    

EISAI REQUIRES ALL NEW HIRES TO BE FULLY VACCINATED AGAINST COVID-19 AND PROVIDE VALID PROOF OF VACCINATION AS OF THEIR START DATE, TO THE EXTENT PERMITTED UNDER STATE LAW. THIS REQUIREMENT IS A CONDITION OF EMPLOYMENT AT EISAI, AND IT APPLIES REGARDLESS OF WHETHER THE POSITION IS LOCATED AT AN EISAI SITE, FIELD BASED OR IS FULLY REMOTE. IF YOU ARE UNABLE TO RECEIVE THE VACCINE DUE TO A MEDICAL CONDITION (INCLUDING PREGNANCY-RELATED), OR BECAUSE OF YOUR SINCERELY HELD RELIGIOUS BELIEFS, YOU WILL HAVE AN OPPORTUNITY TO REQUEST A REASONABLE ACCOMMODATION.

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:

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