Posted to MedZilla on 10/14/2019


Takeda Pharmaceuticals

US-MA, Manager/Senior Manager Viral Vector Manufacturing and Material Supply R0011570-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/Senior Manager Viral Vector Manufacturing and Material Supply in our Cambridge office.

POSITION OBJECTIVES:

The role will develop and implement a viral vector manufacturing strategy to support the Takeda cell therapy program. The position will oversee the selection of external partners, manage supply chain risk and implement forecasting models to ensure optimal level of supply. In addition the role will have responsibility to implement KPIs and ensure that proper governance models are in place to manage the external partners.

ACCOUNTABILITIES:

  • Ensure supply of viral vectors to support clinical trials including Lenti, gamma Retro and AAV vectors
  • Lead the selection and management of CDMOs globally for all of Takeda s viral vector requirements
  • Partner closely with the strategic sourcing and other business functions to continuously drive the efficiencies in the cost per batch while maintaining the highest levels of quality
  • Oversee/Manage all viral vector demand and create a production plan for selected CDMOs and lead the oversight team
  • Critically analyze upstream and downstream purification protocols both internally and externally to maximize yield
  • Execute and manage production orders for viral vectors and develop storage and stability plans
  • Plan and manage future supplies and safety stocks for cell banks and critical materials used in viral vector manufacturing plasmids, cell lines and other raw materials
  • Collaborate with Quality to ensure GMP practices are followed by external partners and implement appropriate controls
  • Responsible for the development of Supply Chain strategy, program timelines, and budgets
  • Lead the supply chain strategy for other critical materials used in manufacturing as needed

EDUCATION, EXPERIENCE AND SKILLS:

Education and Experience:

  • Masters degree or higher in Life Sciences or related discipline,
  • 5+ years of related experience in biopharmaceutical manufacturing with experience in lenti, gamma retro and AAV manufacturing campaigns
  • Strong technical knowledge in viral vector manufacturing and ability to manage multiple CDMO relationships and build supply risk mitigation plans
  • Strong leadership and an innate ability to collaborate and build relationships is critical
  • Flexible and comfortable working with ambiguity
  • Ability to problem-solve and work in complex environment
  • Good understanding of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements (EMA, TGA)

Knowledge and Skills:

  • Teamwork Ability to work well in a fast-paced multi-disciplinary environment
  • Communication - Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor
  • Analytical and Problem-Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information
  • Organization Exercises good time management and prioritization skills and can successfully manage multiple tasks simultaneously
  • Motivated Self-motivated and willing to accept temporary responsibilities outside of initial job description

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.

#LI-TRL

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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