Scientist, Analytical Outsource & Stability at Eisai in Exton, Pennsylvania

Job Description:

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 position is a Subject Matter Expert (SME) providing technical expertise relating to method development, product release and characterization, assessment of stability, validation of assays, and- when appropriate- personally performing the assays and techniques, while serving as a first-line resource in assessing and resolving technical issues at CMOs and CROs. Techniques used include but not limited to compendial, HPLC, ELISA, LC-MS, real time PCR, spectrophotometry, capillary electrophoresis, SDS-PAGE, and other technologies suited to assessment of recombinant protein-based biopharmaceuticals. The candidate aids in developing assays, authors and updates SOPs on analytical test methods and laboratory procedures, and investigates and documents assay failures and OOS/OOT events, and implements associated laboratory CAPA at CMOs and CROs. The ability to function in a fast-paced, highly-technical environment, and communicate effectively is essential to success

ESSENTIAL FUNCTIONS

* Subject Matter Expert (SME) providing technical expertise relating to method development, product release and characterization, assessment of stability, validation of assays, and- when appropriate- personally performing the assays and techniques

* Support technology transfers of analytical methods by co-leading efforts in vendor due diligence exercises, review and/or author of all technology transfer related documents.

* Review laboratory data for release, characterization, assessment of stability, validation of assays, and support of process development while serving as a first-line resource to internal and CMO/CRO analysts in assessing and resolving technical issues.

* Mentor and train other analysts in theory and practice of assays. Assess and document CMO/CRO analytical proficiencies and readiness to perform various types of analyses.

* Mentor/manage the development or optimization of assays as needed to support current and future programs.

* Prioritize, schedule, and monitor multiple multifaceted analytical projects, ensuring timely completion.

* Negotiate service contracts with external providers.

* Author and maintain SOPs, forms, protocols and other controlled documents.

* Aid in the administration the external stability program, ensuring regulatory compliance, adherence to protocols and timely completion of results at each time point.

* Work with CMOs in investigating and documenting assay failures and OOS/OOT events. Aid in identifying and implementing CAPAs.

REQUIREMENTS

* BS or MS in biological or chemical sciences or equivalent

* Minimum of 8-10 yrs working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.

* Exhibits a complete understanding of principles, concepts, practices and standards in QC 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 with recombinant proteins.

* Working knowledge of biopharmaceutical development through all clinical phases and pre-commercialization

* Strong working knowledge of cGMP/ICH/FDA/EMA regulations and guidelines

* Ability to independently identify, investigate, and resolve assay problems.

* Strong written and oral communication skills and good interpersonal skills.

* Team player who can excel in a hands-on entrepreneurial environment.

* Physical requirements: handling of laboratory equipment, chemicals, and biological materials.

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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