Posted to MedZilla on 3/22/2018

Takeda Pharmaceuticals

US-MA, Bioanalytical Research Investigator (BS/MS)- Translational Biomarker Research 1703448-MZ


Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Research Investigator, Bioanalytical Chemistry in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Research Investigator working on the Translational Research team, you will be empowered to work with global development teams and contribute to the bioanalytical strategy for multiple clinical programs, and a typical day will include:

  • Under supervision, or independently executes or oversees clinical bioanalytical chemistry support for two or more compounds, ensuring that bioanalytical support is completed in a timely manner, meets current scientific and quality standards, and adequately supports global regulatory submissions
  • Scope of responsibility includes LC-MS/MS bioanalytical assay method development, transfer, and validation at qualified vendors
  • Incumbent is also responsible for coordination of sample analyses at bioanalytical vendors, monitoring bioanalytical vendors to ensure quality, assay results, and bioanalytical reports
  • Responsibilities include support for LC-MS/MS biomarker assays
  • Responsible for providing strategic input and scientific expertise to global project teams on all issues relevant to bioanalytical chemistry
  • Expected to independently manage and resolve any problems or issues relevant to bioanalytical chemistry while keeping manager informed of critical issues in a timely manner
  • Under supervision, contributes to or may be responsible for developing and implementing the bioanalytical chemistry strategy for two or more global development programs, including vendor selection and oversight of assay development or transfer
  • Supports clinical studies by providing input during synopsis and protocol preparation, and overseeing sample analyses at the bioanalytical vendor
  • Under consultation with supervisor, responsible for providing scientific and technical oversight to the bioanalytical vendor during method development, transfer, validation, or production (including on-site audit of data)
  • Responsible for delivery of preliminary and final assay results.
  • Provides scientific expertise to Clinical Pharmacologist or Translational Scientist for troubleshooting bioanalytical issues in clinical studies
  • Responsible for ensuring final assay reports are complete and accurate and meet regulatory filing requirements
  • Provides input to appropriate sections of clinical study reports (CSR)
  • Responsible for preparing and/or providing input on global regulatory documents including:
    • Investigational New Drug Applications (IND)
    • Regulatory Briefing Documents, Investigational Brochures (IB)
    • Investigational Medicinal Product Dossiers (IMPD)
    • Common Technical Documents (CTD) as the basis for New Drug Applications (NDA) in the U.S. and Market Authorization Applications (MAA) in the EU
    • IND annual reports
    • EMA/CHMP documents
    • Scientific white papers
  • Represent Takeda at external meetings and conferences as well as establish the reputation of Takeda with key opinion leaders, practitioners, partners and agents, and the public at large
  • Collaboratively interact with scientists from other functional areas in TREC, as well as from other Takeda divisions, affiliates, and alliance partners
  • Identify and recommend improvements to departmental processes


  • Educational degree is expected in a relevant scientific area, e.g., Chemistry, Biochemistry, etc.
  • M.S. and minimum 3 years of regulated bioanalytical chemistry or other relevant experience
  • B.S. and minimum 5 years of regulated bioanalytical chemistry or other relevant experience
  • Drug development experience from a regulated bioanalytical chemistry perspective is required
  • In depth, expert knowledge of bioanalytical chemistry, including HPLC and mass spectrometry (MS/MS) analysis techniques
  • Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, and pharmaceutical science is expected
  • Basic understanding of drug development and global regulatory requirements
  • Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents
  • Ability to be an effective member of multi-disciplinary project teams
  • Familiarity with Scope of Work/Task Order development and CRO management


  • Routine demands of an office based environment


  • Some domestic and international travel to Takeda sites, bioanalytical vendors, and regulatory agencies may be required


  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

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