Posted to MedZilla on 11/20/2017

Takeda Pharmaceuticals

US-MA, Manager II, Quality Control Commercial Quality Operations 1702154-MZ


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 II, Quality Control Commercial Quality Operations in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager II, Quality Control Commercial Quality Operations working on the Quality Control team, you will be empowered to bring knowledge of Biologics and lead a team within the Quality Control organization. A typical day will include:

  • Manage oversight of analytical test methods at contract manufacturing organizations and contract testing organizations for Biologics products.
  • Lead method troubleshooting, improvements and implementation activities within and outside Takeda.
  • Lead Method Validations and Transfer activities to CTOs.
  • Conduct and resolve analytical investigations and deviations.
  • Lead training and on-boarding activities for new employees.
  • Author and review analytical sections of regulatory filings and responses to Health Authorities.
  • Liaise with Analytical Development groups to bring knowledge to QC.
  • Ensure validation meets ICH guidelines and methods are QC user friendly.
  • Review analytical sections and response to questions for initial regulatory filing.
  • Provide scientific support as needed to members of QC.
  • Initiate Change Controls to change vendor test methods.
  • Provide QC representation for CMC and regulatory team meetings.


  • Bachelors or a Masters degree in Analytical Sciences or Life Sciences.
  • Extensive experience in analytical method development, qualification and validation of assays of biologics products. Experience with Bioassays and impurity assays such as FACS Binding, Adhesion, HCP and Protein A is a plus.
  • 10 + years experience in pharmaceutical or bio-pharma preferred with at least 2 years of supervisory experience.
  • Computer skills preferably include Word, Excel, Trackwise or electronic document repositories, experience with SAS JMP a plus.
  • Up to 10% 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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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

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