10 days old

Lead Investigator

Baxalta U.S., Inc.
Lexington, MA 02421
  • Job Code
    R0033807

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Job Description

OBJECTIVES/PURPOSE

  • The Lead Investigator, part of the Global Manufacturing Sciences organization, provides technical and methodological leadership for complex and/or high impact process/product investigations, following Advanced Problem Solving and 6-sigma methodology.
  • In addition, he/she provides methodological and technical support to the internal and external sites/network for large cross-products/cross-sites process improvements, and operational efficiency initiatives related to robustness/yield/efficiency increase across the network.
  • Key to this function is to efficiently coach, drive and leverage the dedicated local technical support and global product support teams to achieve their goals.

ACCOUNTABILITIES

  • Provide technical and methodological leadership for complex and/or high impact process/product investigations.
  • Define, deploy and continuously improve a standard problem solving methodology for process investigations. Own the business process and establish the operating mechanisms.
  • Drive alignment of best manufacturing practices across Global Manufacturing Sciences and the Operating units taken from investigations or process improvements.
  • Stay current with and share across Takeda the industry/academia best practices relevant to biologics, plasma, and small molecules manufacturing
  • Implement and maintain a knowledge database for investigation root causes, and pro-actively address vulnerabilities and common causes of issues.
  • Designs and analyzes efficient experiments to optimize use of resources to collect information for investigations, validations, and process improvements.
  • Support identification and execution of cross-products/cross-sites process improvements

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

  • Bachelor degree in technical / scientific education, preferably biochemistry, biotechnology or pharma - process engineering is essential
  • With a Bachelors degree, at least 7 years professional experience in a similar role in the field of Technical Operations, Process Management or Development, Manufacturing within the pharmaceutical industry.
  • 6-sigma certified (Green or Black-Belt) with demonstrated experience in Technical Problem Solving is strongly desired.
  • Prior experience of managing global teams in a matrix is preferred
  • Please note: Role requires 25-50% travel, sometimes on short notice.

This position excludes Colorado applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Sponsored by:
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Lead Investigator

Baxalta U.S., Inc.
Lexington, MA 02421

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