Scientist II, Analytical Outsource

Scientist II, Analytical Outsource & Stability Join Eisai US as a Scientist II in Analytical Outsource & Stability. This role leverages analytical science expertise to guide methods development, supervise release and stability testing, and manage external CRO/CODM performance. Job Responsibilities Provide technical expertise and direction to the development and validation of phase‑appropriate analytical methods to support current and future programs. Lead development of product specifications. Proficiency in the use of statistical tools is essential. Prioritize, schedule, and monitor analytical projects, ensuring timely completion. Review and approve stability protocols relating to method development, product release and characterization, assessment of stability, validation of assays, and‑when appropriate‑personally performing the assays and techniques. Negotiate service contracts with external providers. Assess and document CMO/CRO analytical proficiencies and readiness to perform various types of assays. Support analytical method transfers by co‑leading vendor due diligence activities as well as review and/or author all method transfer related documents. Review laboratory data to support product release, characterization, stability assessment, assay validation, and process development, while serving as a primary technical resource for internal teams and CMO/CRO analysts in troubleshooting and resolving analytical issues. Work with CMOs in investigating and documenting assay failures and OOS/OOT events. Help in identifying and implementing CAPAs. Help in the administration of external stability programs, ensuring regulatory compliance, adherence to protocol requirements and timely completion of results at each time point. Author and maintain SOPs, forms, protocols and other controlled documents. Draft regulatory documents to support IND/IMPD/BLA/MAA filings. Present assay/stability study results and related findings to relevant project stakeholders. Qualifications & Skills PhD or equivalent academic degree in a relevant scientific discipline with a minimum of 2 years of post‑doctoral experience in the industry or academia (or a combination of equivalent education & experience). Complete understanding of principles, concepts, practices and standards in GMP testing of biopharmaceuticals, including a thorough understanding of industry practices. Extensive hands‑on experience in HPLC, capillary electrophoresis, ELISA, gel‑based assays and other relevant assay technologies used for the analysis of recombinant proteins. Demonstrated knowledge of biopharmaceutical development through all clinical phases and post‑commercialization. Strong familiarity with cGMP/ICH/FDA/EMA regulations and guidelines. Exceptional communication skills within own team and cross‑functionally, presenting insightful assessments of analytical data. Ability to work closely and influence external partners/CMOs/CROs. Independent identification and investigation of assay‑related issues and formulation of hypotheses and/or experimental design to support effective solutions. Ability to identify and implement improvements to methods/assays and processes. Demonstrated knowledge of plate‑based and other potency assays is a must. Salary & Benefits The base salary range for the Scientist II, Analytical Outsource & Stability is from $113,400 to $148,900 per year. This position is eligible to participate in Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including experience, education, knowledge and skills. Employees are eligible to participate in Company employee benefit programs. For additional information, visit Certain other benefits may be available for this position; please discuss any questions with your recruiter. Equal Employment Opportunity Eisai is an equal‑opportunity employer and 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. Eisai prohibits discrimination against persons because of disability, including disabled veterans. E-Verify Participation 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. #J-18808-Ljbffr