Eisai US
Scientist II, Analytical Outsource & Stability
Eisai US, Exton, Pennsylvania, United States, 19341
Overview
Scientist II, Analytical Outsource & Stability at Eisai US. This role focuses on analytical sciences, supporting methods development, release and stability testing, product characterization, and assay validation. The position involves coordinating with CMOs/CROs, hands-on testing in the lab when needed, and guiding external partnerships to meet project timelines. Effective communication in a fast-paced, highly technical environment is essential. 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. 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 and review and/or author all method transfer documents. Review laboratory data to support product release, characterization, stability assessment, assay validation, and process development; serve as a primary technical resource for internal teams and CMO/CRO analysts in troubleshooting analytical issues. Work with CMOs to investigate and document assay failures and OOS/OOT events; help identify and implement CAPAs. Administer external stability programs, ensuring regulatory compliance 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
Academic/PhD in a relevant scientific discipline with minimum 2 years of post-doctoral experience in a relevant technical field, or an equivalent combination of education and experience. Strong understanding of GMP testing for biopharmaceuticals and industry practices. Extensive hands-on experience in HPLC, capillary electrophoresis, ELISA, gel-based assays and other relevant assays for recombinant proteins. Knowledge of biopharmaceutical development through all clinical phases and post-commercialization. Familiarity with cGMP/ICH/FDA/EMA regulations and guidelines. Effective communication within teams and cross-functionally; ability to influence external partners/CMOs/CROs. Ability to investigate assay-related issues and design experiments to support solutions; identify and implement improvements to methods and processes. Demonstrated knowledge of plate-based and other potency assays. Salary Transparency
The base salary range for the Scientist II, Analytical Outsource & Stability is 113,400 – 148,900 USD. Eligible for Eisai Inc. Annual Incentive Plan. Final pay determinations depend on factors including experience, education, knowledge, and skills. This role may participate in Company employee benefit programs. For benefits information, visit the Eisai careers page. Eisai is an equal opportunity employer and participates in E-Verify. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing Location notes: Exton, PA area; other listed locations may vary by posting. References to other roles and generic notices have been removed for clarity.
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Scientist II, Analytical Outsource & Stability at Eisai US. This role focuses on analytical sciences, supporting methods development, release and stability testing, product characterization, and assay validation. The position involves coordinating with CMOs/CROs, hands-on testing in the lab when needed, and guiding external partnerships to meet project timelines. Effective communication in a fast-paced, highly technical environment is essential. 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. 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 and review and/or author all method transfer documents. Review laboratory data to support product release, characterization, stability assessment, assay validation, and process development; serve as a primary technical resource for internal teams and CMO/CRO analysts in troubleshooting analytical issues. Work with CMOs to investigate and document assay failures and OOS/OOT events; help identify and implement CAPAs. Administer external stability programs, ensuring regulatory compliance 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
Academic/PhD in a relevant scientific discipline with minimum 2 years of post-doctoral experience in a relevant technical field, or an equivalent combination of education and experience. Strong understanding of GMP testing for biopharmaceuticals and industry practices. Extensive hands-on experience in HPLC, capillary electrophoresis, ELISA, gel-based assays and other relevant assays for recombinant proteins. Knowledge of biopharmaceutical development through all clinical phases and post-commercialization. Familiarity with cGMP/ICH/FDA/EMA regulations and guidelines. Effective communication within teams and cross-functionally; ability to influence external partners/CMOs/CROs. Ability to investigate assay-related issues and design experiments to support solutions; identify and implement improvements to methods and processes. Demonstrated knowledge of plate-based and other potency assays. Salary Transparency
The base salary range for the Scientist II, Analytical Outsource & Stability is 113,400 – 148,900 USD. Eligible for Eisai Inc. Annual Incentive Plan. Final pay determinations depend on factors including experience, education, knowledge, and skills. This role may participate in Company employee benefit programs. For benefits information, visit the Eisai careers page. Eisai is an equal opportunity employer and participates in E-Verify. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing Location notes: Exton, PA area; other listed locations may vary by posting. References to other roles and generic notices have been removed for clarity.
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