Posted to MedZilla on 11/20/2017


Takeda Pharmaceuticals

US-MA, Manager II Quality Control - Release and Stability Management 1702160-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 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:

POSITION OBJECTIVES:
  • 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.

POSITION ACCOUNTABILITIES:

  • 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.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • 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
TRAVEL REQUIREMENTS:
  • Up to 10% travel
WHAT TAKEDA CAN OFFER YOU:
  • 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
Learn more at takedajobs.com.

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 http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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