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

Responsibilities

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

    Supervision

  • 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

Technical

  • 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

    General

  • 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)

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
  • 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.


Please visit our website at takedajobs.com

 
 


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