Senior Associate, CMC Program Management

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. Job Summary The primary focus will be to coordinate Drug Substance (DS) CMC activities for Eisai product candidates. This includes preparing and maintaining project schedules, budgets and resource requirements in support of activities in Process and Analytical Development, Process Transfer, Quality Control and Manufacturing as well as Regulatory Submissions. Project Management experience in the development and manufacturing of biologics is a requirement. Essential Functions Prepare and maintain project schedules, budgets, and resource requirements in support of activities in process development, analytical development, process transfer, quality control and manufacturing activities. 25% Track expenditures to meet overall budget goals set by managers. Follows function’s financial standards, guidelines and compliance requirements. 15% Provide support to Management in assessing resource needs to achieve timelines and program milestones. Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs. 20% Tracks project metrics and consolidate documentation relative to project milestones. Work with the CMC Regulatory Department to develop timelines for regulatory filings (e.g., INDs and BLAs); communicate with CMC team to ensure all CMC sections of regulatory filings are of high quality and completed on-time 15% Facilitate meetings (eg project team meetings, biopharmaceutical council meetings), and coordinate meeting logistics including scheduling meetings, sending out agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting. 20% Support cross-function project management activities as assigned. 5% Requirements 3 years of industry experience in the development of biologic products. BS in Biological Science or Engineering is required MS/PHD in Biological Science or Engineering, PMP is a plus Strong Project Management experience managing CMC development programs for protein biologic programs. Working knowledge of cGMPs and familiarity with relevant ICH Guidance documents Experience in the generation of regulatory filings (INDs and BLAs). Strong leadership and communication skills. Experience in a biologics manufacturing environment or interactions with Contract Manufacturing Organizations (CMO) is a plus, but not required. Proficient in relevant software: MS Project, Excel, PowerPoint, Word, Visio, etc. in addition to general knowledge with shared work environments 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 applicable 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 for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation #LI-HC1 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 applicable 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 for qualifying medical reasons (including pregnancy-related), or religious reasons (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: Right To Work E-Verify Participation