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Sr Scientist, Bioanalysis for New Modality, DMPK at Eisai in Cambridge, Massachusetts

Posted in Other 30+ days ago.

Type: Full Time





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.

DMPK expertise for bioanalysis for new modalities is essential to drug discovery and development at all stages. The primary roles of Senior Scientist, Bioanalysis for New Modality are:

* Identify needs, set objectives, design and conduct experiments including PK and PK/PD studies, and deliver accurate and critical results for addressing bioanalytical-related issues in drug discovery, development and clinical new modality projects.

* Directly influence project directions to promote project advancement/discontinuation

* Have responsibility for identification, evaluation, and implementation of necessary improvements to current processes that have a direct impact on operational outcome, data quality, and productivity of DMPK-Cambridge unit.

* Represent DMPK department effectively in multidisciplinary teams.

* Serve independently as the expert in a specific scientific area, serve as the prime contact for both internal and external collaboration partners, and prepare study reports or manuscripts for regulatory submissions or peer-reviewed journal publication

* Mentor junior scientist

* Contribute to formulation of BA-CFU annual objectives

* Serve as a company-wide resource in one or more areas of expertise

ACCOUNTABILITIES

* Sets objectives, delivers results and implements polices and operational targets that have a direct impact on the work unit or operational outcome

* Work may include policy changes or recommendations

* Individual contributor with specialized knowledge

* Has an easily discernable impact on the job area and expected results

* Typically does not have budget management responsibility

COMPLEXITY / INNOVATION

* Executes work procedures in a project context. Exercises judgment within defined procedures and policies

* Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments

* Called upon to develop solutions utilizing creativity and ingenuity

COMMUNICATION

* Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues

* Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity

SUPERVISION GIVEN / RECEIVED

* Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees

* Work is completed under limited supervision

* Typically reports to a Principal Scientist / Associate Director or above.

ESSENTIAL FUNCTIONS

* Advocate the use of new methods and techniques to support research programs. Use emerging developments in relevant scientific fields to generate new research ideas and initiatives. Lead projects and / or implement technologies that span across several functions; leading larger or more complex efforts. Execute series of experiments with a high level of independence. (55%)

* Advocate the use and need for new technology to support research plans. Ensure the best processes are used for all research projects within project scope. (10%)

* Lead the preparation and submission of patents. Lead the preparation of scientific publications beyond discipline or integrated disciplines. May lead the preparation of regulatory documents as applicable in collaboration with the legal department. Oversee and interpret information from team members. (20%)

* Influence project directions to promote product creation goals. Interpret and integrate data to make recommendations for critical discovery/technology project decisions. Consult with outside collaborators, consultants, and contract services to improve research projects. Set priorities, budgets, timelines, and project goals for multiple project teams that span several disciplines. (10%)

* Complies with all applicable laws and regulations of each country in which we do business. Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reports legal, compliance and ethical violations in a timely manner. (5%)

REQUIREMENTS

* PhD degree with sufficient experience (5 or more years of experience)

* Solid understanding of bioanalysis of nucleic acid and antibody drug including antibody-drug-conjugate using hybridization ELISA and Ligand binding assay and assay development and validation workflows.

* Proficient in the current regulatory guidelines and industry standard practices for bioanalytical assay development, validation, sample analysis, result delivery, and record keeping.

* Excellent knowledge and experience in bioanalysis using LC-MS/MS

* Excellent knowledge and experience in in vivo and in vitro approaches for evaluation of pharmacokinetics and drug metabolism.

* Excellent knowledge and experience in laboratory information management system and standard software packages for data and pharmacokinetics analysis, such as WinNonlin, GraphPad, and SigmaPlot.

* Familiar with approaches for assessment of drug efficacy and toxicity.

* Excellent Familiar with approaches for assessment of drug efficacy and toxicity verbal and written communication skills and strong interpersonal communication skills.

* Some experience mentoring or supervising junior scientists.

* Willing to travel up to 10% (travel to Japan and CROs required), availability for early morning/evening tcons

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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