Posted to MedZilla on 5/23/2019

Takeda Pharmaceuticals

US-MA, Manager, Investigational Medicinal Product Quality Advanced Therapies QC Microbiology R0007846-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 a Manager, Investigational Medicinal Product Quality Advanced Therapies QC Microbiology in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager working on the Investigational Medicinal Product Quality Advanced Therapies team, you will be empowered to drive the overall operation and continuous improvement of an internal GMP Microbiology QC laboratory, environmental management program and the aseptic techniques associated with manufacturing cell therapy Investigational Medicinal Product (IMP) utilized in Takeda clinical studies, and a typical day will include:


  • This position conducts microbiological testing in the microbiology lab and directly manages contract testing laboratories associated with microbiology testing such as bioburden, Mycoplasma molecular detection, microbiological identification and sterility for cell therapy products.
  • This position is responsible for start-up activities for the microbiology lab and establishment of quality system supporting aseptic practices (gowning, monitoring, cleaning and related training).
  • This position leads a microbiology QC team in the microbiology lab.


  • Oversee aseptic practices (gowning, monitoring, cleaning and related training) in the internal cell processing GMP facility.
  • Manage and conduct environmental monitoring, in-process testing and release testing for microbiology to support the manufacturing of cell therapy drug product manufactured in the internal GMP facility.
  • Manage contract testing laboratories associated with microbiological testing for the IMP manufactured at the internal GMP facility.
  • Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
  • Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
  • Ensure general lab readiness and manage laboratory equipment qualification and maintenance.
  • Implement and maintain standards of safety to ensure the Microbiology lab kept clean, safe and tidy all the times.
  • Supervise microbiological analysts in the microbiology lab.
  • Work closely and collaboratively with cross-functional team (e.g. QA, QC lab, production team, analytical development scientists) as the microbiology lead.
  • Additional duties as assigned.


  • Bachelor s Degree in Microbiology or other relevant field. Masters preferred.
  • Minimum of 7 years experience in the bio/pharmaceutical industry
  • Minimum of 5 years experience in GMP QC/laboratory with increasing responsibility
  • Thorough knowledge of GMP and current FDA & EMA regulations
  • Experience of leading other microbiology analysts and scheduling daily activities including environmental monitoring
  • Strong microbiology knowledge and practical experience of microbiology testing including sterility, endotoxin, mycoplasma and environmental management, with the ability to act as a subject matter expert
  • Experience with writing and reviewing SOPs for QC laboratories
  • Previous experience in setting up a new microbiology laboratory is desirable
  • Knowledge and experience of Lean Laboratories is preferable
  • Excellent organizational, communication, interpersonal and report writing skills
  • Demonstrable experience managing, motivating and leading a team
  • Ability to adapt to changing priorities


  • In general, the position requires a combination of sedentary work and standing for extended periods of time in the microbiology laboratory.
  • This role supports pharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities, packaging, component printing and analytical laboratories (this list is not exhaustive).


  • Requires approximately 5% or less domestic 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

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Cambridge, MA

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Full time

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