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Senior Scientist, Process Development (Fixed-Term Contract)

応募 後で応募 求人ID R0010130 掲載日 07/02/2019 Location:Singapore, Singapore

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Job Description

OBJECTIVES :

  • Design, manage and execute studies pertaining to Vaccine Process Development. 
  • Conduct experiments to establish, optimize and qualify manufacturing methods for the production of live attenuated and purified inactivated viral vaccines.
  • Analyze data from studies, method development, or tech transfer activities, and author reports for submission to multiple parties, including regulatory agencies such as the FDA and EMA.
  • Oversee Scientists in managing programs conducted by both in-house employee and at 3rd party vendors.

ACCOUNTABILITIES :

  • To lead in various laboratory operations in the development and application of manufacturing methods for biological products.
  • Conduct experimental procedures to establish, optimize and qualify downstream technologies for vaccines manufacturing.
  • Responsible for participating in new product technology transfer, and process qualification and validation activities.
  • Preparation of technical memorandum, protocols, reports, summaries, and quantitative analysis, for the distribution and/or presentation to project teams, and for regulatory agency submissions.
  • Support his/her supervisor in project development strategies and planning and execution of deliverables.
  • Interface with contract manufacturing and testing organizations (CMOs and CTOs) to achieve projects deliverables within the specified timeline.
  • Design of experiment, execution, analytical analysis and/or oversee studies performed in-house to achieve process development targets.
  • Analysis of experimental data using statistical approaches.
  • Develop new processes or improve existing processes / methods by leveraging from journal articles and/or from knowledge of other scientists.
  • Provide expertise to support function scientists, third parties, and other functions, to achieve the project goals and priorities.
  • Write and maintain accurate, complete, and timely data in laboratory notebooks and quality records.
  • To support and participate in daily laboratory operations and maintenance.
  • Participate in new development programme technology transfer to advance the VBU portfolio pipeline.
  • Local and/ or overseas training attachment will be expected.

EDUCATION, EXPERIENCE, SKILLS :

  • PhD in a scientific discipline with a minimum of 2 years industry experience (may include post doctoral experience), MSc in a scientific discipline with a minimum of 4 years industry experience, or a BSc in a scientific discipline with a minimum of 6 years industry experience
  • Knowledge of chromatography, process techniques and equipment as related to biopharmaceutical process development, such as methods producing and purifying biological molecules, at medium to large scale, are essential
  • Proven ability to understand the theoretical basis and objectives of experiments and how they fit into overall project goals.
  • Experience/knowledge of cGMP practices as applicable to downstream virus manufacturing processes, process development, analytical development, formulation and/or technology transfer is desirable
  • Familiarity with current applicable scientific literature and applicability to various projects
  • Good oral communication and demonstrable, exemplary writing skills
  • Ability to investigate and develop new processes and technologies for project advancement.
  • Well organized and detail oriented, with ability to effectively prioritize tasks, eager to learn, interact cooperatively and effectively with others in a team environment, and consistently demonstrate reliability and responsibility.
  • Experience with Statistics and Design of Experiment (DoE) as applied in an industrial biopharmaceutical environment will be a distinct advantage
  • Team player with initiative & drive Comply with Takeda safety practices and standard operating procedures.
  • Exhibit and promote Takeda Core Competencies.
  • Fixed Term Contract

TRAVEL REQUIREMENT :

  • May require some international travel, approximately 5 - 10%

Locations

Singapore, Singapore

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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