Posted to MedZilla on 11/13/2019

Takeda Pharmaceuticals

US-MA, Lead, Process Scientist, Drug Product R0010788-MZ


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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 an Associate Director, Technical Operations in our Cambridge Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director, Technical Operations working on the Technical Operations team, you will be empowered to enhance and innovate manufacturing processes and be the technical thought leader related to Takeda Oncology and Biologics products, and a typical day will include:


  • Provide technical expertise within the GMSci DP/Pkg organizations relating to manufacturing technology and sciences for drug product manufacturing.

  • Servesas the SME for leading major technical transfer or validationprojectsrelating to new productintroduction or life cycle management of existingproducts

  • Provides leadership for regulatoryinteractionsincluding CMC content for dossiers

  • Ensuresprocessknowledgeisshared and leveragedacrosssites and functions

  • ServesasTakeda s global DP SME for issueresolutionasneeded


  • Serves as Takeda s expert on small molecule OSD or parenterals process and technologies
  • Lead the following activities, along with Pharmaceutical Sciences and/or Operation Units:Drug Product Manufacturing Process Characterization,Technology Transfer to both CMOs or internal manufacturing facilities,Drug Product manufacturing and packaging process validation and serves as the experts for deployment as rapid response teams to serve all local manufacturing Operating Units
  • Manage projects within Takeda product portfolio, both development and commercial, to support Manufacturing Sciences DP and Packaging Science activities
  • Implementstrategies for the continuous improvement on the manufacturing of Marketed Products (a.k.a. matured products) in the late phase of the product life cycle

  • Implement the manufacturing strategy for key Takeda products at internal manufacturing network and CMOs

  • Accountable for successfulcollaboration with: Manufacturing Operating Unit Site leads,Local Technical Services functions,PharmaceuticalSciencescounterparts,Otherkeyfunctionalgroupssuchas Global Quality, Regulatory CMC, etc.


  • BS in Chemistry, Chemical Engineering or other related disciplines and 10 to 15 + yrs of industrial experience working in a commercial technical environment
  • Working knowledge of solid dosage drug product manufacturing operations or sterile parenteral production
  • Minimum 10 years experience in pharmaceutical development and manufacturing
  • Previous experience in serving as a SME lead in a matrix environment relating to drug product manufacturing


  • Position requires up to 30 - 45% domestic and international travel.


  • 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

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Boston, MA

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Full time

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