Research Investigator Analytical Development

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Research Investigator Analytical Development

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Research Investigator Analytical Development with the following duties: Independently design, plan and execute studies on new development candidates to elucidate fundamental physicochemical properties and behaviors that enable lead candidate selection and downstream CMC development; contribute to a cross-functional Pharmaceutical Sciences team responsible for overseeing API salt and polymorph selection and subsequent development activities; use analytical techniques offline and potentially inline to characterize API form and morphology development; develop non-GLP and GLP formulations based on the physical chemical properties of molecules and their route of delivery to support pre-clinical studies; includes the use of in-silico assessments; conduct biorelevant in vitro studies to assess potential in-vivo performance and impact of API and drug product changes during development lifecycle; be responsible for significant or sole technical leadership within a project and support project strategy development across projects within the department or cross functionally; interface with individual Pharmaceutical Science colleagues and cross functional project teams to ensure that development activities are consistent with physicochemical properties of API; represent functional area on departmental or cross functional teams communicating and aligning Pharmaceutics Research activities and milestones; collaborate with Drug Safety to transfer formulations to CRO’s for non-GLP and GLP toxicology studies; may serve as a technical expert in mentoring junior team members; integrate scientific and technical efforts around cross functional issues; plan and implement resolutions to technical problems and issues; support local initiatives which may include technical or process related work streams; author technical reports and contributes to regulatory filings. Up to 10% domestic travel required; Up to 20% remote work allowed.

REQUIREMENTS: Bachelor’s degree in Chemistry, Analytical Chemistry, Biology, Pharmaceutical Sciences, Materials Science and engineering, or other Life Science related degree plus 5 years of prior experience OR Master's degree in Chemistry, Analytical Chemistry, Biology, Pharmaceutical Sciences, Materials Science and engineering, or other Life Science related degree plus 3 years of prior experience.  Prior experience must include: Develop early-stage formulations of active pharmaceutical ingredients (APIs) to enable in-vivo animal studies, optimizing drug product properties, and supporting initial pharmacokinetic and toxicology assessments; Conduct solid state physical and chemical characterization using HPLC, PXRD, TGA, DSC, DVS, SEM, and FTIR, etc., to evaluate solid state stability, and form/structural properties for optimal formulation development; Develop and execute analytical methods (HPCL, GC, MS, KF etc) for API and Drug Products to enable characterization of materials key properties and stability to ensure quality and enable development of processes (i.e. purity, assay, identification); Design and execute biopharmaceutics studies of drug candidates to assess formulation performance and facilitate drug candidate selection; Develop simulation and mathematical models and utilize in-silico tools, including GastroPlus, Phoenix WinNonline, etc., to predict drug candidate properties and in vivo drug performance that enable optimization of drug products, and potentially aid in regulatory submissions.

Full time. $108,600.00 - $165,600.00 per year. Competitive compensation and benefits.

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0149050. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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