Scientist II, Analytical Outsource & Stability

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 person will have demonstrated expertise in the analytical sciences and will be expected to provide guidance to methods development, supervise release and stability testing activities; direct product characterization and assay validation. The individual may be required to perform hands-on testing in the lab and will be expected to be a resource for resolving technical issues at CMOs and CROs. The individual will have demonstrated expertise in such procedures and techniques as compendial methods, HPLC, ELISA, LC-MS, qPCR, UV spectrophotometry, CE-SDS, SDS-PAGE, and their use, singly or in combination with other techniques, to test and characterize protein-based biopharmaceuticals. The person will author protocols; reports; author and revise SOPs and lead investigations into assay failures, OOS/OOT events; direct the implementation of CAPAs and evaluate their effectiveness. This position primarily oversees analytical testing and characterization at external laboratories and will be expected to effectively manage the alliance with the CROs/CDMOs to meet project timelines. The ability to function in a fast-paced, highly technical environment, and ability to communicate effectively are essential.

Job Functions

• 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 transfers 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.

Required Qualifications & Skills

• Academic/PhD in relevant scientific discipline with minimum 2 years of post-doctoral experience in relevant technical field (industry or academia) (OR) Combination of equivalent education & experience in an earlier role/ comparable role along with demonstrated skills listed below.

• Exhibits a 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.

• Ability to communicate effectively within own team and cross-functionally and presents insightful assessments of analytical data.

• Ability to work closely and influence external partners/CMOs/CROs.

• Ability to independently identify and investigate assay-related issues and formulate 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.

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://us.eisai.com/careers-at-eisai/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.

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