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
- 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.
- 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%