Eisai Inc., Eisai Medical Research and Eisai Corporation of North America are U.S. subsidiaries of Tokyo-based Eisai Co., Ltd., a research-based human health care company, that discovers, develops, and markets products throughout the world.
At Eisai (a-zi), caring for people is our work. Satisfying unmet medical needs and increasing benefits to patients, their families, and caregivers is Eisai's human health care (hhc) mission. This includes the development of innovative medicines-notably the discovery of the world's most widely used treatment for Alzheimer's disease.
As a company growing at a fast pace, Eisai offers its employees opportunities to thrive. We recognize that our people are our greatest asset, and are committed to providing a work environment that will attract and retain talent. Eisai enables and empowers all employees to make significant contributions. That is our quest. That is our promise. That is what makes us Eisai.
With more than 2,500 employees in the U.S. and sites located in Woodcliff Lake, NJ, Ridgefield Park, NJ, Baltimore, MD, and Research Triangle Park, NC, we work and live by our values: Integrity, Respect, Professionalism, Quality and Teamwork.
The Manager is responsible for managing analytical testing performed by Quality Control (QC) on inactive and active ingredients, packaging components, and in-process and stability samples. This is achieved by administering activities such as planning/scheduling all laboratory testing workloads to meet objectives of Production Operations; ensuring cGMP/Regulatory/Safety compliance for laboratory testing, documentation, investigations, instrumentation/equipment, and training; and hiring, coaching and developing staff. He/she drafts or contributes to all QC formal laboratory documentation, including investigation reports, validation and stability protocols, regulatory submissions, specifications and standard test methods, standard operating procedures, and test documentation including LIMS, worksheets, and laboratory notebooks. He/she represents QC on cross-functional department teams involving Eisai/RTP, Eisai Company Ltd., and external partners and companies. All of the activities mentioned above performed with periodic supervision. Additional duties include:
Manage QC staff to achieve the goals and objectives of Production Operations and Quality Control. This includes planning/scheduling laboratory workloads, as well as hiring, training, coaching, and managing performance of QC staff members.
Review or prepare documentation of all laboratory work (e.g., test results, investigations, instrumentation/equipment preventative maintenance and calibration) in accordance with cGMP, cGLP, or SOPs, as appropriate. Ensure all laboratory work is conducted in compliance with applicable safety and environmental regulations.
Represent QC at departmental meetings and on cross-functional department teams involving Eisai/RTP, Eisai Company Ltd., and external partners and companies. (Includes travel, as needed, to support business objectives.)
M. S. or Bachelors in Chemistry or equivalent discipline, with appropriate experience (Typically 6-8 years), OR Associate degree or High School Diploma with appropriate equivalent experience (Typically 12 + years)
Experience with variety of instrumental and wet chemical methods, including trouble-shooting laboratory instrumentation
Experience with problem-solving, especially for handling out of specification data
Knowledge of cGMPs
Knowledge of laboratory safety
Strong interpersonal communication skills
At Eisai (a-zi), caring for people is our work. Satisfying unmet medical needs and increasing benefits to patients, their families, and caregivers is Eisai's human health care (hhc) mission. This includes the development of innovative medicines-notably the discovery of the world's most widely used treatment for Alzheimer's disease.
As a company growing at a fast pace, Eisai offers its employees opportunities to thrive. We recognize that our people are our greatest asset, and are committed to providing a work environment that will attract and retain talent. Eisai enables and empowers all employees to make significant contributions. That is our quest. That is our promise. That is what makes us Eisai.
With more than 2,500 employees in the U.S. and sites located in Woodcliff Lake, NJ, Ridgefield Park, NJ, Baltimore, MD, and Research Triangle Park, NC, we work and live by our values: Integrity, Respect, Professionalism, Quality and Teamwork.
The Manager is responsible for managing analytical testing performed by Quality Control (QC) on inactive and active ingredients, packaging components, and in-process and stability samples. This is achieved by administering activities such as planning/scheduling all laboratory testing workloads to meet objectives of Production Operations; ensuring cGMP/Regulatory/Safety compliance for laboratory testing, documentation, investigations, instrumentation/equipment, and training; and hiring, coaching and developing staff. He/she drafts or contributes to all QC formal laboratory documentation, including investigation reports, validation and stability protocols, regulatory submissions, specifications and standard test methods, standard operating procedures, and test documentation including LIMS, worksheets, and laboratory notebooks. He/she represents QC on cross-functional department teams involving Eisai/RTP, Eisai Company Ltd., and external partners and companies. All of the activities mentioned above performed with periodic supervision. Additional duties include:
Manage QC staff to achieve the goals and objectives of Production Operations and Quality Control. This includes planning/scheduling laboratory workloads, as well as hiring, training, coaching, and managing performance of QC staff members.
Review or prepare documentation of all laboratory work (e.g., test results, investigations, instrumentation/equipment preventative maintenance and calibration) in accordance with cGMP, cGLP, or SOPs, as appropriate. Ensure all laboratory work is conducted in compliance with applicable safety and environmental regulations.
Represent QC at departmental meetings and on cross-functional department teams involving Eisai/RTP, Eisai Company Ltd., and external partners and companies. (Includes travel, as needed, to support business objectives.)
M. S. or Bachelors in Chemistry or equivalent discipline, with appropriate experience (Typically 6-8 years), OR Associate degree or High School Diploma with appropriate equivalent experience (Typically 12 + years)
Experience with variety of instrumental and wet chemical methods, including trouble-shooting laboratory instrumentation
Experience with problem-solving, especially for handling out of specification data
Knowledge of cGMPs
Knowledge of laboratory safety
Strong interpersonal communication skills