Posted to MedZilla HealthCare on 10/23/2018

Takeda Pharmaceuticals

US-MA, Manager II, Quality Control - Specialty and Biologics R0004382-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 II, Quality Control on our Oncology and Biologics Commercial Quality team in our Cambridge 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 Compliance team within Release and Stability Management, you will be empowered to ensure Takeda s products meet all quality standards. A typical day will include:


  • Manage oversight of test laboratories at contract manufacturing organizations and contract testing organizations for Oncology & Biologics Commercial products for injectable parenterals and oral solid dose products
  • Generate release COAs and stability reports and conduct and resolve analytical investigations and deviations
  • Review and/or provide analytical information for regulatory filings and responses to Health Authorities
  • Lead training and on-boarding activities for new QC employees.


  • Ensure release and stability study points are performed on time, the testing is compliant, and that test documentation and results are captured in Takeda electronic systems.
  • Conduct Out Of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and drive to closure. Collaborate with GMSO (Global Manufacturing Supply Operations) as needed.
  • Initiate Deviations, Investigations, Corrective/Preventative Actions (CAPA)
  • Initiate Change Controls to change vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records
  • Generate product trending for all methods and attributes for each product at each assigned site, including ad hoc trending for deviations and investigations
  • Generate performance metrics and participate in audits and inspections by alliance partners and government agencies
  • Provide QC representation for regulatory filing team meetings (e.g. Prior Approval Submissions, renewals/updates/supplements, specific LOC requests)
  • Author Annual Product Review (APR/PQR) for QC batch release/stability sections


  • 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 biopharma preferred with at least 2 years of supervisory experience
  • Job related experience in QC specific to release testing review and assessment of deviations/investigations
  • Ability to collaborate effectively with various cross-functional groups within the company as well as with external vendors. Experience with companies outside the US
  • 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

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