Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MA, Manager, Vaccine Technical Operations R0012371-MZ


 
 

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Job Description

OBJECTIVES

The Manager, Vaccine Technical Operations will be responsible for:

  • Providing technical oversight support as required for sterile process operations being carried out at Takeda s network of manufacturing partners
  • Supporting implementation of manufacturing and quality systems (such as change controls, deviations, etc.) in collaboration with internal and external partners.
  • Working with Development and Operations Teams to plan and manage process improvements, scale-up, technical transfers and life-cycle management.
  • Developing and implementing manufacturing solutions to enhance quality, cost and robustness of vaccine manufacturing processes

ACCOUNTABILITIES

  • Provide scientific and technical support of commercial manufacturing at partners to support corporate goals for supply strategies, productivity, quality, and compliance.
  • Provide ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing
  • Partner with internal and external stakeholders communicate, escalate and resolve program issues both within Takeda and with external manufacturing partners
  • Partner with engineering to provide process inputs for process fit assessments and to define process requirements for new manufacturing facilities.
  • Working cross-functionally, develop robust proposals for scale-up and technology transfer of vaccine products, and for life-cycle management changes.
  • Lead cross-functional teams for engineering, qualification and validation of new and existing vaccine manufacturing facilities / processes and technology transfers
  • Build partnerships in the areas of engineering and process equipment to drive awareness of new technologies for best in class manufacturing operations.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS with a minimum of 5 years experience or MS with a minimum of 3 years experience in start-up, tech transfer, and/or sustaining cGMP for commercial sterile process operations in vaccines or biopharmaceuticals.
  • Scientific and technical knowledge regarding CIP/SIP, formulation processes, aseptic filling, isolator technology, lyophilization and visual inspection.
  • Demonstrated expertise in process transfer for drug product operations, including formulation/filling, lyophilization and/or visual inspection
  • Experience in single use technologies, and the ability to manage vaccine-specific nuances and strategies. Experience working with live viruses is a plus
  • A self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of structured product development
  • Proven ability to work with efficiency across multiple project teams and business functions in a matrix environment.
  • Able to lead and manage technical teams, serve as a partner and influence others. Demonstrated cross-functional team experience.
  • Willingness to travel
  • German language considered a plus.

TRAVEL REQUIREMENTS:

  • 20% domestic and international

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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