Posted to MedZilla on 10/13/2019

Takeda Pharmaceuticals

Singapore-, Process Sciences Lab Lead SR0040768-MZ


Primary Objectives of this Job

  • Leading and supervision of Manufacturing Sciences laboratory group or teams
  • Responsible for fulfillment of internal and external guidelines for process development, scaled-down models and material use tests
  • Define, plan, monitor and review the provision of personal resources for experiments and tests within the laboratory
  • Support manufacturing operations with studies and data gathering
  • Support facility start-up operations during technology transfer or new process implementation
  • Responsible for the evaluation of process improvements and design of experiments
  • Responsible for establishing and maintaining qualified scaled-down models to perform supporting Process Performance Qualifications (PPQs).
  • Develop investigational scaled-down models/experimental design to support Manufacturing deviations.
  • Assist in the definition of validation and scale-up requirements
  • Definition of training requirements and responsible for training of dedicated laboratory employees
  • Reporting to management/supervisor
  • Responsible for creation and release of area specific quality relevant laboratory documents
  • Responsible for technical input and technical assessments of product characterization, process technologies
  • Manage resources within the Global Manufacturing Sciences laboratory resources
  • Manage laboratory budget, and lab related capital expenditure where applicable


Organization activities

  • Organizational responsibility and coordination of laboratory activities (scheduling and monitoring)
  • Supervisor and leader of dedicated employees
  • Interface position between various Manufacturing Sciences group as well as quality and manufacturing
  • Responsible for providing personal resources for studies/experiments
  • Responsible for periodic reporting to Management
  • Maintenance of laboratory equipment and systems
  • Responsible for maintenance process of scaled down models/ QbD models
  • Responsible for process improvement evaluation and definition


  • Independent Planning and Organization of employees in accordance to Management requirements
  • Regular preview of pending activities to meet Manufacturing Sciences matrix requirements
  • Scheduling of projects
  • Personnel organization of the laboratory group
  • Management of dedicated staff and development/ Manage budget for laboratory
  • Able to represent site for technical discussions and contribute to division initiatives
  • Forecasting of requirements and workload balance for laboratory, highlighting critical deficiencies to management


  • Oversee the design, planning and execution of experiments/studies in the lab to ensure they are fit-for-purpose and meet customer requirements
  • Provide guidance and technical oversight in the approval of Scale Down Model qualification protocols and reports to assure reliable, fit-for-purpose process models are established within the lab
  • Collaborate with key internal partners including Pharm Sciences, process validation, Manufacturing Sciences and quality.
  • Interface with vendors for technical support, where applicable


  • Focused on the customer satisfaction: product quality (safety, efficacy), timeline, costs
  • Represent site in cross site technical discussion, give presentation on behalf of the site
  • Provide site recommendation on technical issues
  • Direct team on technical and scientific developments/literature within the area of expertise
  • Comply with c-GMP, EHS and other requirements
  • Commit to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct
  • Mentor, coach, develop and lead the Manufacturing Sciences group

Education and Experience Requirements

Educational background:

  • At least Bachelor s 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
  • Technical expertise on small scale fermentation, chromatography and filtration
  • Experience in a biologics small scale lab environment
  • Knowledge of DOE
  • Understanding of process validation support (e.g. functionality studies, small scale life cycle validation etc.)
  • 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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