Posted to MedZilla on 9/15/2019

Takeda Pharmaceuticals

US-MA, GMP Senior Manager/Associate Director Cell Therapy Manufacturing Operations R0007901-MZ


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Job Description

Senior Manager/Associate Director Cell Therapy Manufacturing Operations

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 Manager/Associate Director Cell Therapy Manufacturing Operations in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager/Associate Director Cell Therapy Manufacturing Operations working on the Research and Development team, you will be empowered to establish the Takeda cell therapy manufacturing team, focused on providing new treatments to patients while promoting a safe, teamwork driven work environment. A typical will include:


The GMP manufacturing senior manager/associate director will be responsible for overseeing and managing the daily operations of Takeda s new cell processing facility in Cambridge, Massachusetts. Initially, the position will serve as a subject matter expert in developing internal business processes, writing SOP s and assisting with the commissioning and qualification of the facility. This position will directly contribute to the successful delivery of product in support of numerous clinical trials.


  • Establish the Takeda cell therapy manufacturing team, focused on providing new treatments to patients while promoting a safe, teamwork driven work environment
  • Train, supervise and mentor GMP production personnel
  • Ensure all training requirements are up-to-date for manufacturing associates and personnel performing operations in the facility
  • Maintain all manufacturing areas in accordance with GMP requirements and company SOP s, ensuring inspection readiness at all times
  • Assist with scheduling of personnel to support production runs
  • Represent manufacturing interests during the construction of the new clinical cell therapy production facility
  • Assist with initial and ongoing facility qualification and IQ/OQ of process equipment
  • Partner with Quality, supply chain and facilities to ensure timely delivery of product to patients
  • Ensure GMP facility, process equipment and required materials are available, maintained and qualified as required for the different manufacturing campaigns
  • Assist with investigations, CAPA implementation and continuous improvement of production SOP s
  • Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and functions
  • Collaborate with tech transfer group to complete the implementation of GMP production processes
  • Identify and mitigate risks in manufacturing operations that may impact patient safety
  • Review and approve documents, including standard operating procedures, batch records, material specifications and validation protocols and reports


  • Bachelor s degree in life science or engineering, equivalent work experience may also be considered
  • 8+ years of relevant GMP manufacturing experience with a minimum of 2 years managing hands-on manufacturing operations
  • In-depth knowledge of FDA regulations and GMP requirements and general awareness of international regulations and standards
  • Extensive experience in GMP cleanroom operations, including aseptic processing
  • Working understanding of Quality, EHS and supply chain functions
  • Previous mammalian cell culture experience is required
  • Knowledge of cell therapy manufacturing, culture and handling of human primary cells and cryopreservation preferred
  • Experience with electronic systems (ERP, LIMS, MES, EBR) would be useful
  • Strong leadership skills with ability to motivate staff members and develop a culture of operational excellence


  • Teamwork Ability to work well in a highly cross-functional team environment
  • Communication - Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely; timely and effectively communicates issues to supervisor and team members
  • Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems, determine causes and determine and implement solutions
  • Organization Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
  • Motivated Self-motivated and willing to accept temporary responsibilities outside of initial job description


  • Willingness to travel to various meetings or Takeda sites


  • 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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Boston, MA

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