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 ensures the Biologics Pilot Plant (BPP) operations and quality control functions comply with cGMP regulations (Japan, EU and US), Industry Standards and Eisai corporate quality expectations, and the company's hhc mission. This includes, but is not limited to; production, testing and disposition of Biological Drug Substance (BDS) or Antibody Drug Intermediate (ADI), raw materials and cell banks at the BPP and at CMOs/CROs for clinical and commercial use. This position is also responsible for ensuring that the internal and external quality management system/processes will support cost effective provisions of BDS, ADI, raw materials and cell bank. The quality oversight responsibilities at the BPP include both development and commercial quality functions.
This position will be the key member of the BPP Commercialization Committee, to contribute to the strategic decisions and directions, and execute actions to establish site commercial quality systems and readiness.
This position will also lead the continued development, implementation, and maintenance of phase appropriate GxP quality management systems and compliance for biological products from pre-clinical through commercial launch as the Development Quality Assurance (DQA) team.
This position is responsible to select and manage CMO/CRO for BDS and ADI manufacturing and analysis from a quality perspective including auditing and ensuring PAI readiness.
The position will maintain collaborative working relationship and effective communication within DQA and internal customers, such as Pharmaceutical Science and Technology (PST), Eisai Demand Chain System (EDCS), Global Product Quality Headquarters (GPQ), Regulatory Affairs and external parties.
Provide oversight and leadership to ensure that the quality of biologics for clinical and commercial use will comply with cGMP regulations (Japan, EU and US), Industry Standards and Eisai corporate quality expectations to ensure that the site is inspection ready.
Contribute to the strategic decisions and directions to establish readiness to manufacture and test biologics for commercial use as a delegate of the Quality organization. Execute actions as planned and assigned.
Direct management and teams to maintain QMS and/or continually evaluate current policies, procedures and practices to develop and implement continuous improvements in the BPP.
Other examples of responsibility :
Provide quality oversight to internal/external organizations for the manufacture and analysis of BDS or ADI, raw materials, cell banks and critical intermediates.
Provide Quality support for the review and data verification of BLA/MAA/JNDA as well as auditing of the source information.
Identify and report any critical quality incidents to DQA Head, Head of Americas Quality, and subsequently to Chief Quality Officer (CQO).
Supervise people managers/individual contributors and provide guidance and leadership. Manage employee-related activities including performance management and development. Identify resource needs. Participate in recruitment, and compensation planning for assigned employees.
Serve as the Quality contact for the site with regards to interactions with regulatory agencies and business partners. Leads regulatory inspections and partner audits.
Serve as a delegate of the Quality organization for the BPP Commercialization Committee, a member of the Strategic Operations Meeting and lead the Quality Council Governance Committee. Attend Eisai Biopharmaceutical Council meetings as appropriate.
Develop department budget and ensure the department is committed to financial targets.
Develop/review/approve quality agreements, and/or SOPs associated with PQ and DQA activities.
In partnership with senior management, establish a quality culture and philosophy at the site which will guide the development of policies, practices, procedures, and standards by which all site operations are performed; provide quality assurance input to Eisai strategic goals.
Facilitate the setting of both short-term and long-term goals of the QA operations group and ensure accountability for achieving results
Bachelor's degree in Biology, Chemistry, Engineering or related sciences. Master's degree, preferred
Minimum 12 years of experience in a cGMP environment for pharmaceutical products, including minimum 5 years of experience working with biologic products in commercial manufacturing. Monoclonal antibody-based bulk drug substance experience strongly preferred.
Minimum 5 years of leadership experience in a Quality organization.
Advanced knowledge and experience with biologics regulatory expectations for Quality Assurance, Quality Systems, QC and GMP's.
Advanced knowledge of manufacturing and testing of biologics.
Experience in facilitating and supporting regulatory audits (FDA, EMEA, PMDA, etc.) in support of pre-approval and general inspections.
Technical and scientific judgement.
Excellent problem solving and decision making abilities.
Self -motivated individual comfortable working with detailed information and data.
Excellent organizational skills
This position is expected to be physically present at the site (not a remote role)
Excellent verbal/written communication and interpersonal skills.
Strong presentation skills.
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.
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