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Senior Scientist – Biophysical Characterization

Lexington, Massachusetts

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Senior Scientist – Biophysical Characterization

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Job ID R0019175 Date posted 05/13/2020 Location Lexington, Massachusetts

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Job Description

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 Senior Scientist in Structural Characterization team located in our Lexington office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.

As a Senior Scientist – Biophysical Characterization, you will be joining the Structural Characterization US team to support the biologics development at Analytical Development – Biologics (AD-Bio). In this role, you will be empowered to:

  • Develop project specific technical strategy in biophysics and lead the department’s biophysical and particulate characterization work. Perform lab work when needed.
  • Train, scientifically mentor junior staff members on biophysics and be technically responsible as a subject matter expert within the department.
  • Prepare and coordinate completion of method transfer documentation, CMC sections of regulatory documents, validation plans and reports, or support GMP and non-GMP investigations within areas of expertise.
  • Manage the outsourcing and execution of biophysical work at CROs.
  • Coordinate cross-functional teams and resolutions, with a focus on scientific/technical challenges across the range of biologics modalities within Takeda’s diverse pipeline.
  • Remain current and lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed to build Takeda’s cutting-edge scientific capabilities.

POSITION ACCOUNTABILITIES:

  • Develops and leverages strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of decisions within AD-Bio and other functions in Pharmaceutical Sciences.
  • Manages the outsourcing of biophysical work at CROs for biologics characterization e.g. RS qualification, structure/function studies, comparability and investigations.
  • Manages key vendor relationships across multiple projects as appropriate, and proactively affects resolution of issues arising at vendors.  
  • Reviews, interprets and communicates data internally and cross-functionally (e.g., to supervisor, project teams) and prepares technical reports.
  • Coordinates others in creating technical reports including reviewing and editing.
  • Serves as a technical expert for junior staff and leverages expertise as a functional resource/trainer.
  • Contributes significantly to complex/multiple projects or functional areas through leading or influencing others.
  • Influences and supports initiatives related to drive scientific and technical improvement within function and cross-functionally.
  • Significant technical responsibility for biophysics within AD-Bio and potentially across the broader Pharmaceutical Sciences.
  • Defines complex and novel approaches to solve complex technical challenges 
  • Represents AD-Bio as a functional lead on CMC project teams
  • Identifies topics for initiatives and leads local & global initiatives.
  • Coordinates within departmental as well as cross functionally with peers on project work.
  • Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.

POSITION REQUIREMENTS

  • Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience
  • Experience in CMC pharmaceutical development for biologics and working in a multi-disciplinary team environment
  • Previous experience with the use of contract facilities is a plus.
  • Significant hands-on experience with a broad variety of biophysical techniques, including but not necessarily limited to AUC, CD, DSC, DSF, DLS, MALS, fluorescence, FTIR, particle quantitation and characterization tools, and/or other spectroscopic-based methods for biologics.
  • Able to lead cross-program development activities for multiple biophysical technologies.
  • Able to conduct troubleshooting for complex technical issues for biophysics and to lead major characterization studies and biophysical/particulate related investigations. 
  • Experience with biochemical characterization assays such as liquid chromatography, gel or capillary electrophoresis and mass spectrometry is a plus.
  • Experience with statistical principles for biophysical data analysis is a plus.
  • Strong understanding of protein structure/function and of technical and regulatory expectations regarding analytical development and product characterization.
  • Able to lead evaluation and implementation of new equipment/technologies.
  • General lab competencies such as equipment maintenance and compliance activities. 
  • Able to work collaboratively and to provide effective technical leadership within a matrixed organization 
  • Familiarity with GMP and regulatory guidelines and prior experience on a project team will be a plus.

TRAVEL:

  • May require approximately 5% travel.

WHAT TAKEDA CAN OFFER YOU:

  • 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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Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0019175

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