Scientist

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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: Lexington, MA

POSITION : Scientist

POSITION DESCRIPTION : Takeda Development Center Americas, Inc. is seeking a Scientist with the following duties: Provide theoretical/conceptual input to the design, development and execution of research assignments (e.g., formulation screening by design of experiment, analyze data and create predictive models for protein stability); plan and execute characterization and optimization experiments (protein conformation and chemical stability) and develop new screening tools (e.g., chromatography, protein particle analysis); review, interpret and communicate data cross-functionally teams; understand drug product developmental project timelines and deliverables; plan, coordinate and communicate project strategy and complex data/decisions (e.g., protein stability data, drug product manufacturing process data) with departmental, functional and external stakeholders to support clinical studies and commercial. Up to 20% remote work allowed.

REQUIREMENTS: Ph.D. degree in Biochemistry and Molecular Biology or related field plus 1 year of related experience. Prior experience must include: Characterize, analyze and evaluate biologic drug substances or drug products with biochemical and biophysical techniques including liquid chromatography (LC), electrophoresis, peptide mapping, glycan mapping, quantitation of polysorbates, silver staining, freeze-drying microscopy (FDM), differential scanning calorimetry (DSC), differential scanning fluorimetry (DSF), subvisible particle analysis via micro-flow imaging (MFI) and HIAC system, FTIR, osmolality measurement, etc.; Develop and qualify analytical test method such as the quantitation of the polysorbates in drug products and drug substances, design studies according to the ICH guidelines to quantitatively evaluate the linearity, intermediate and repeatability precision, specificity, limit of detection, limit of quantitation of the method, and set the acceptance criteria of test results; Setup and manage stability studies using aseptic techniques to aliquot samples, assigning sampling timepoints according to long-term, intermediate or accelerated storage conditions, collecting samples accordingly and allocating testing among colleagues and CRO partners, analyzing result and communicating cross-functionally; Design studies to isolate and characterize the subject biologic materials such as polysaccharides, proteins and nucleic acids; Perform experiments such as cell or tissue culture, preparation and screening of hybridomas for monoclonal antibody, polymerase chain reaction (PCR), liquid chromatography (LC), gas chromatography (GC), electrophoresis, mass spectrometry (MS), nuclear magnetic resonance (NMR), immunoassays, lyophilization, dynamic light scattering (DLS), UV-Vis spectroscopy, etc.; Troubleshoot throughout the process to improve analytical methods and enhance yield; Analyze the data, draw conclusions from the results, and propose scientific and industrial applications of the study.

Full time. $111,800 - $191,600 per year. Competitive compensation and benefits.

Qualified applicants can apply at . Please reference job #R0161093 . 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.