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

Responsibilities

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

    General

  • 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)

Experience:

  • 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.


Please visit our website at takedajobs.com

 
 


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