Research Investigator / Scientist, Formulations
Location:
Cambridge , Massachusetts
Posted:
December 18, 2017
Reference:
1701937

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 / Scientist, Formulations in our Cambridge facility.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Research Investigator / Scientist working on the Formulation Development team, you will be empowered to prepare and execute complex experimental protocols, analyze and interpret data, and collaborate on cross-functional teams. A typical day will include:

OBJECTIVES:
  • Participate in the preparation and review of appropriate internal and external documents such as Development Reports, Technical Transfer and Validation Protocols/Reports, Investigational New Drug Applications (IND), and New Drug Applications (NDA).
  • Provide onsite technical support at a Contract Manufacturing Organization (CMO) during development and manufacturing of clinical trial material (CTM), including cGMP manufacture of CTM to support Phase I-III programs in several therapeutic areas with a focus in Oncology.
  • Partner with other groups on the GCT, ensure Formulation Development activities are fully supported and aligned with other GCT functional groups such as Analytical Chemistry, Process Chemistry, Clinical Supply Coordination, and Quality Assurance.
  • Represent the Formulation Development group as a member of a Global CMC Team (GCT) by providing technical leadership related to the formulation and manufacturing of drugs for human use. Design and execute research studies and utilize data to characterize and further optimize formulation and associated manufacturing processes.

ACCOUNTABILITIES:
  • Independently designs, executes and interprets studies aimed at developing suitable formulations and associated manufacturing processes.
  • Assists other members of the GCT with the development of project strategy and communicates complex data/decisions within department and cross functionally.
  • Contributes significantly to project work which may include multiple projects within functional area.
  • Reviews, interprets and communicates data internally (e.g., to supervisor, project teams) and prepares technical reports and regulatory documents.
  • Proposes and implements resolutions to technical problems/issues
  • Supports local initiatives as directed by supervisor and participates in global CMC or functional initiatives as appropriate.


Qualifications:



EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Associates degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 7+ years relevant industry experience
  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 5+ year’s relevant industry experience
  • Hands on experience with development and manufacturing of small molecule solid formulations of highly potent and insoluble compounds
  • Hands on experience with common solid dosage form manufacturing processes such as milling, blending, granulation (high shear, fluid bed, and roller compaction), fluid bed drying, encapsulation, tablet compression and film coating
  • Hands on experience with development and manufacturing of small molecule solid formulations of highly potent and insoluble compounds
  • Hands on experience with common solid dosage form manufacturing processes such as milling, blending, granulation (high shear, fluid bed, and roller compaction), fluid bed drying, encapsulation, tablet compression and film coating.


TRAVEL REQUIREMENTS:

  • 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

Empowering Our People to Shine

Learn more at takedajobs.com .

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

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A little about us:
Takeda fosters an inclusive environment where all employees are empowered to shine.

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