Scientist, Bioanalysis for New Modality, DMPK

  • Anywhere

Company :
Eisai US

Location :
Cambridge, Massachusetts

Expiry Date :
Fri, 18 Dec 2020 23:59:59 GMT

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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. Role The primary roles of Scientist, Bioanalysis for New Modality (especially oligonucleotides) are DMPK expertise for bioanalysis for new modalities is essential to drug discovery and development at all stages. – Identify needs, set objectives, design and conduct experiments, and deliver accurate and critical results for addressing bioanalytical-related issues in drug discovery, development and clinical new modality projects. Especially require scientific expertise to conduct bioanalysis of oligonucleotides (e.g., develop, validate, and run hybridization-ELISA assays). – 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. – Show the results of the studies that will have a significant impact on project milestone advancement. – Represent DMPK department effectively in multidisciplinary teams. – Serve independently as the expert in a specific scientific area and serve as the prime contact for both internal and external collaboration partners. – Provide scientific and technical coaching to other staff members. – Manage resources and organize workflow to achieve objectives of the department and the projects. Accountabilities – Sets objectives, delivers results and implements polices and operational targets that have a direct impact on the work unit or operational outcome – Individual contributor with specialized knowledge – Work may include policy changes or recommendations – 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 – Develop and validate in-house bioanalytical method for new modalities based on requirements by regulatory agencies and/or using state-of-the-art technology. Identify sources and lead team efforts to optimize laboratory productivity and streamline analytical workflow. Provide DMPK-related contributions toward project advancement by suggesting, planning, and executing in vitro and in vivo studies to collect critical ADME properties of new modalities. Represent the DMPK-C department in multidisciplinary project teams. Close collaboration with Eisai global bioanalytical teams and external CROs. Evaluate and prioritize research efforts to characterize DMPK properties within broader team objectives. (50%) – Identify and introduce new experimental techniques to address research issues. Justify, propose, assess and lead the introduction of new technologies and/or projects. Identify and solve significant problems related to project. Execute experiments with a high level of independence. (10%) – Anticipate needs and plan for the purchase, use, and maintenance of laboratory equipment. Follow best established procedures and provide recommendations to conduct research. (10%) – Draft the preparation and submission of patents / portions of patents. May lead preparation of scientific publications in a discipline. May draft regulatory documents with consultation of the legal department. Oversee and interpret experimental results from direct reports. (10%) – Drive collaboration across research groups and communicate results to colleagues within project context. Present research results for company reviews. Set priorities for project team members within own discipline to ensure team completes projects on time and within budget. (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. (10%) Requirements – PhD (or BA/BS or MS degree with sufficient experience) – Skillful in conducting bioanalysis of nucleic acid using hybridization ELISA and familiar with 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. – Familiar with bioanalysis using LC-MS/MS – Excellent knowledge and experience in in vivo and in vitro approaches for evaluation of pharmacokinetics and drug metabolism. – Familiar with approaches for assessment of drug efficacy and toxicity. – Familiar with laboratory information management system and standard software packages for data and pharmacokinetics analysis, such as WinNonlin, GraphPad, and SigmaPlot. – Excellent verbal and written communication skills, and strong interpersonal communication skills. – 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. Please Click On The Following Link For More Information 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. Right To Work E-Verify Participation