Posted to MedZilla on 10/13/2019

Takeda Pharmaceuticals

Singapore-, Process Sciences Upstream Lead SR0040767-MZ


Primary Objectives of this Job

  • Supervise teams to support manufacturing operations (Upstream)
    • Plan, coordinate and allocate resources for process investigations and technology evaluation
    • Plan, lead and coordinate the implementation improvements and/or optimizing processes
    • Define and set up process monitoring systems and decide on escalation of process issues
    • Define and determine strategic requirements and resources for increasing process understanding
  • Supporting the manufacturing, engineering and validation groups
    • Support and allocate resources for commissioning, qualification and validation activities.
    • Provide technical support to support functions
  • Support technology transfer for new technologies and products
    • Set up, lead and manage Technology Transfer initiatives
    • Perform facility-fit assessment and define start-up requirements, including validation, process/product characterization requirements
    • Plan, lead and coordinate Stage 2 Process Validation and Stage 3 Continued Process Verification
    • Plan, lead and coordinate Material Qualification activities (as required)
    • Provide process training as required
    • Define and set up QbD approach
  • Represent Manufacturing Sciences in cross department discussions and decision making
  • Manage budget, welfare and development of Manufacturing Sciences team


Planning and Escalation

  • Independent Planning and Organization of employees and activities to support Organizational goals and requirements
  • Scheduling and resource allocation for all Manufacturing Sciences activities (including but not limited to projects, commissioning, cycle development, investigations, Tech Transfers)
  • Regular preview of pending/ongoing activities to meet Manufacturing Sciences matrix requirements and appropriate escalation to management
  • Forecasting of requirements and workload balance for employees, highlighting critical deficiencies to management

    Management and Technical Supervision

  • Analyze process trends and monitor process performances to maintain robust manufacturing process (quality, capacity)
  • Lead/support critical investigations to resolve process and quality issues (Identify root cause, corrective action)
  • Lead/support manufacturing/material/quality exceptions and provide product/process impact assessments.
  • Improve process performance and identify and implement yield improvement initiatives.
  • Monitor progress and effectiveness training programs and train manufacturing leaders/trainers
  • Review and approve technical reports and engineering documents such as URS, FS etc
  • Support regulatory inspections and filings
  • Lead Tech Transfers and Process Installation: Planning, monitoring, budget/resource preparation


  • Focused on the customer satisfaction : product quality (safety, efficacy), timeline, costs
  • Represent site in cross site technical discussion and support divisional initiatives
  • Provide site recommendation on technical issues
  • Manage budget, welfare and development of Manufacturing Sciences team
  • Direct team on technical and scientific developments/literature within the area of expertise
  • Mentor, coach and lead the Manufacturing Sciences group
  • Responsibility to adhere to any applicable c-GMP and EHS requirements
  • Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct
  • Serve as a delegate to the Head of Manufacturing Sciences when necessary

Any other duties as assigned by Head of Manufacturing Sciences.

Education and Experience Requirements

Educational background:

  • At least Bachelor degree in biochemistry, chemistry, chemical engineering, biotechnology, biochemical engineering with 8 years of relevant experience. Master s degree with 6 years of relevant experience or PhD with at least 3 years experience desirable (Specific area of expertise)


  • Hands-on experience with cell culture/ upstream/ downstream/chromatography processes in a manufacturing or process development environment
  • A combination of work experience or training in the respective area of specialization
  • Good knowledge of cGMPs
  • Solid technical and process understanding, Ability to write technical and scientific reports
  • Team worker/ able to work in matrix environment
  • Good communication skills, esp. in different cultural environment
  • Strong analytical skills including critically and objectively/ logical thinking
  • Proactive and Independent worker/ Self starter
  • Good sense of Integrity and Leadership experience, especially in a matrix environment

Key Skills and Competencies

  • Experience in leading technical teams
  • Project experience ideally
  • Organizational and presentation skills, ability to work in a team
  • Knowledge and practical experience in process development and protein/cell culture characterization

Management skills

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

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