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Senior Manager , Oncology & Bi...

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Job Summary

Company
Takeda
Location
Boston, MA
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4314_R0003383

Senior Manager , Oncology & Biologics, Commercial Quality Control

About the Job

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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 Sr. Manager, Quality Control in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Title working on the Oncology and Biologics Quality Control team, you will be empowered to ensure our patients receive a product of the highest quality and a typical day will include:

POSITION OBJECTIVES:

  • Oversee quality control activities for the Entyvio Drug Product project and Brigatinib API project
  • Responsible for the release and stability testing of the commercial batches, preparation of annual Product Quality Reviews
  • Support of regulatory submissions and management of the contract service providers

POSITION ACCOUNTABILITIES:

  • Oversee vendor management of quality control product activities for biologic pharmaceutical manufacturing sites.
  • Oversee vendor management for product release and stability activities for the biologic pharmaceutical contract laboratories.
  • Support of vendor management:
  • Lead/ attend weekly conference calls and keep communication with vendor QC/QA counterparts
  • Ensure complete, accurate, and valid quality testing documentation is received by Millennium
  • Resolve Deviations, Out of Specification (OOS)/Atypical (AT) laboratory investigations, Corrective/Preventative Actions (CAPA)
  • Initiate change controls to improve processes, change vendor/Millennium specification documents, update vendor test methods/stability protocol documents

  • For CMOs conducting stability programs:
  • Ensure study points are pulled on-time
  • Manage reporting of raw data and summaries

  • Responsibilities for project and data management:
  • Ensure timely preparation of stability protocols for the upcoming studies
  • Ensure timely review and approval of release and stability data in PDMS
  • Generate Certificates of Analysis and ensure stability reports for the completed stability studies are prepared within approved timelines.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BS or MS Science, 10-15 years of experience in pharmaceutical industry
  • Bachelor’s Degree with 6 years of experience or related biopharmaceutical compliance experience
  • A minimum of three (3) years people management experience
  • Knowledge of cGMP regulations for US, EU and other markets
  • Effective time management, detail oriented, organizational skills, teamwork and collaboration
  • Strong computer (proficiency in Microsoft Word, Microsoft Excel and Power Point with Track Wise and or Cats Web training desirable), verbal and written communication skills

TRAVEL REQUIREMENTS:

  • Up to 25% 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.

No Phone Calls or Recruiters Please.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
 

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