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.

This position manages and provides direction to personnel within the Gliadel Quality Control (QC) department.  The QC department is responsible for the analytical and microbiological testing of active ingredients, raw materials, packaging components, in-process materials, drug product, and the environmental monitoring (EM) program for the Baltimore site. 

The Sr. Manager independently administers activities such as planning/scheduling laboratory workloads; ensuring cGMP/Regulatory/Safety compliance for the QC department, ensuring the integrity of all QC data, the completeness and accuracy of documentation, the thoroughness of investigations, instrumentation/equipment, and training; and hiring, coaching and developing staff. 

The incumbent prepares (and as appropriate also reviews) 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/Empower, worksheets, and laboratory notebooks.

The Sr. Manager represents QC on cross-functional department and leadership teams involving Eisai/Baltimore. Eisai Corp. Ltd., and external partners and companies.  Interacts with regulatory officials to understand requirements and ensure requirements are met for compliance and business needs.  Serves as a site analytical expert during investigations.

This position is also responsible for implementing and managing Eisai’s Americas Region GMP Data Governance and Data Integrity program for the Baltimore site. This includes Data Governance and Data Integrity policies, development and maintenance of Data Integrity Standards and administration of global Data Integrity processes.

Essential Functions

• Manages the activities of the in-house QC laboratory and contract laboratories with respect to the testing of API, raw materials, WIPs and final product. Ensures all laboratory work is conducted in compliance with applicable safety and environmental regulations.

• Manages the activities of the in-house Microbiology laboratory with respect to the Environmental Monitoring (EM) program for the Baltimore site.

• Identify, develop and implement Data Governance and Data Integrity practices and systems for Baltimore site: Develop and implement and maintain data governance and data integrity policies and standards, implement global processes and systems and associated global procedures;; Ensure continuous improvement of Data Integrity program.

• Manages personnel in the QC and Microbiology functions.  Performs annual and as-needed personnel performance evaluations.  Manage Direct Reports over diverse areas; Outline, Monitor and Provide Feedback on Performance. Establishes and maintains a plan that ensures that staff training is current and appropriate. Conducts regular meetings with department personnel to define expectations and goals and ensure that they are met.

• Prepares (and as appropriate also reviews) laboratory documentation, including investigation reports, validation and stability protocols, regulatory submissions, specifications and standard test methods, standard operating procedures, and test documentation, and laboratory notebooks in accordance with cGMP, or SOPs, as appropriate.  Ensures the integrity of QC data.

• Ensures all laboratory work is conducted in compliance with applicable safety and environmental regulations.

• Develops, implements, and maintains appropriate systems and procedures required by the CGMPs for the laboratories.  Proposes and implements revisions to existing programs (continuous improvement).

• Represents QC on cross-functional department teams involving Eisai-Baltimore, Eisai Company Ltd., and external partners and companies.  Represent Laboratory during Regulatory and Customer Audits at Baltimore.  Recommends decisions/course of actions in atypical situations.

• Manage New Projects and Project Changes to Improve QC Systems.  Participate in site projects,, as the QC SME.  Manages department operating and capital budgets consistent with QC business needs.

Requirements

Education:

• B.S./B.A. in Chemistry, Pharmacy or Pharmaceutical Sciences required

• Masters preferred

Technical:

• Minimum 8 years of experience in the Pharmaceutical Industry in Quality Control with demonstrated knowledge and leadership in pharmaceutical analysis. 

• Proficiency in the areas of HPLC, GC, UV, IR, and pharmaceutical analysis required.

• In depth knowledge of cGMPs, USP/EP/JP Testing, and FDA/EMA/PMDA Guidelines.

• Excellent communication skills (oral and written).

• Demonstrated organizational skills.

• Critical thinking with ability to identify issues requiring further attention and ability to initiate and facilitate resolution of those issues. 

• Substantial experience with Root Cause Development.

• Self-starter with ability to work equally well in a team environment and independently.

• Proven ability to multi-task and execute timely follow up.

• Prior supervisory experience required.

• Deep understanding of Data integrity Guidelines, requirements and best practices for EU and US.

• Demonstrated history of successful interactions with regulatory inspectors.

• Understanding of instrument qualifications and laboratory calibration programs.

• Experience with method transfer/validation.

Other Skills/Abilities:

• Knowledge of European Union (EU) and Japanese cGMPs and regulations.

• Knowledge of Microbiology and Clean room Environmental Monitoring requirements and data trending

• Very detail-oriented with the ability to understand and apply the big-picture to projects

  • Will include strong attention to detail to data integrity, document revisions, meeting timelines, etc.

• Demonstrated ability to build and maintain successful relationships across the organization

• Computer skills including a working knowledge of Microsoft Office (Access, PowerPoint, Word and Excel).

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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