Posted to MedZilla on 4/25/2017

Takeda Pharmaceuticals

US-MA, Pilot Senior Manager 1603046-MZ



Manages all activities, both upstream and downstream, within the pilot laboratory at Takeda Boston with a small team of focused staff. This position will have strong interfaces with development, manufacturing, both internal and external, and project management. Must be hands-on and flexible with strong leadership skills in this fast growing capability. Pilot team will be responsible for material supply, scale up process design, trouble-shooting, several aspects of technical transfer and in exploring innovative technology for pilot and cGMP manufacturing. Manages constant effort in continuous improvement for both operational and technical aspects of the pilot team. Identifies and recommends vendors as appropriate. Identifies and plans broader technical objectives (project and department related) and initiates processes to meet objectives with input from manager as needed.


  • Manages a team of both upstream and downstream technical staff personnel
  • Accountable for meeting pilot team objectives such as production of batches for material supply, technical transfer or for development.
  • Responsible for capacity planning and identification of critical risks and needs
  • Responsible for capital and infrastructure planning for pilot facility
  • Coordinates cross-functional teams and resolutions, with a focus on scientific/technical challenges.
  • Develops and leverages strategic understanding of project and CMC priorities to plan/coordinates with cross functional peers and evaluate impact of decisions across CMCC and other development functions
  • Influences or assists initiatives related to driving scientific and technical improvement within function and potentially cross functionally.
  • Contributes significantly and independently to complex/multiple project work through advising and guiding direct reports.
  • Assists with the operations of the group and department including resource planning, process improvements, infrastructure, and initiatives.
  • Reviews, interprets and communicates data cross-functionally within CMC/project teams.
  • Analyzes technical and conceptual risk and trends and advises direct reports
  • Coordinates the work of coworkers and direct reports to create technical reports in own area including reviewing and editing.
  • Contributes to defining departmental operational strategies
  • Provides significant technical leadership for a project area/technical program within the department and potentially across CMCC (i.e. GCT lead).
  • Represents functional area on technical teams and provides guidance on potential impacts of proposed actions on other disciplines/projects.
  • Identifies initiative topics and leads local/global initiatives as directed by senior staff.
  • Defines more complex strategic approaches and methodologies to achieve project goals and influence team members
  • Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals. Proactively resolves issues arising at vendors.



Education and Experience:


  • Bachelors degree in chemistry, biology, pharmacy, or related pharmaceutical science and 11+ years relevant industry experience
  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 9+ years relevant industry experience
  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 3+ years relevant industry experience
  • Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP s
  • Experience with CHO based systems and proteins (particularly antibodies)
  • Sound knowledge of current Good Manufacturing Practices (cGMP) and direct experience with cGMP manufacturing is preferred
  • Previous experience with the use of contract facilities
  • Experience in working in a multi-disciplinary team environment
  • Previous experience contributing to regulatory filings
  • Previous people management experience.

Knowledge and Skills:

  • Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems and determine causes and possible solutions
  • Teamwork -- Works well on global cross-functional teams; Demonstrated ability to foster a highly efficient team environment.
  • Communication Skills -Able to expresses one s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style appropriate for the audience; timely and effectively communicates with senior management and direct reports; technical writing skills to support authorship and approval of technical documents
  • Organization Exercises good time management and prioritization skills to balance multiple project and departmental objectives
  • Technical - Subject matter expertise in a specific scientific area or areas. Demonstrated ability to successfully contribute across multiple scientific endeavors
  • Knowledge Sharing - Ability to capture organizational knowledge organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
  • Resource Management -Project management skills; ability to manage the time of direct reports within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
  • External Involvement Demonstrated involvement in professional community evidenced by presentation of scientific posters or lectures at professional conferences or events. Advises team members or directly interacts with external vendors for projects
  • Leadership Skills Demonstrated ability to manage up and down the organization; Ability to use appropriate management strategies to provide direction for the work of team members and support individual development.


Must be willing to support circumstances which may require weekend and evening coverage.


May require approximately 10% travel


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