Mgr., Biologics External Mfg. Quality (Hybrid)

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:

• Review and approve batch records for DS and DP manufacturing, ensuring compliance and data integrity.
• Assess and approve deviations, investigations, and CAPAs related to DS and DP operations (e.g., EM excursions, media fill failures, process deviations).
• Oversee change controls impacting DS and DP processes.
• Support batch disposition activities to ensure timely and complaint product release.
• Monitor and track manufacturing data for integrity and compliance.
• Ensure CMO compliance with quality systems (change control, deviations, investigations, OOS results, validation, retain sample management).
• Contribute to evaluation of product complaints and regulatory compliance of CMOs.
• Review technical protocols, reports, batch records, and regulatory documentation related to DS and DP manufacturing and validation activities.
• Support development and maintenance of processes and procedures governing quality systems and CMO interactions.
• Collaborate with internal and external stakeholders to drive compliance, continuous improvement and risk mitigation across external manufacturing operations.

Requirements:

• Education: BS/BA in life sciences or engineering (required); advanced degree desirable.
• Experience: 5+ years of Quality experience in biologics DS and DP operations, including aseptic fill-finish.
• Knowledge of EU GMP Annex 1 & Annex 2, FDA aseptic guidance, and global sterility assurance principles.
• Experience with DS processes (cell culture, purification) and DP aseptic operations (media fills, EM trending, contamination control strategies)
• Understanding of Quality System Management (lot disposition, deviations, change management, complaints).
• Strong organizational and communication skills; ability to manage multiple priorities.
• Proficiency in Microsoft Office tools.
• Ability to travel up to 25% (domestic and international).
• Required onsite Tuesday-Thursday

Eisai Salary Transparency Language:

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

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:

Right To Work

E-Verify Participation