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Job Description- Bioprocess EngineerThe Bioprocess Engineer is considered as a key role in development of products, scale up/scale down of processes, upgrading processes and products that may range from incremental improvements to major technology changes and leading complex investigation. The successful candidate will develop improved process strategies, yields, plant capacity and overall performance. May act as technology guardian for a particular unit and/or leverages technical competency across sites. Generates new technology applications. Interacts with internal and external organizations. Mentors other engineers/chemist and assists in operations training. Key responsibilities:
- Lead improvement projects to achieve productivity improvement, quality, compliance and reliability improvements.
- Manage/Co-manage the industrialization phase for new product / new process additions in collaboration with R&D scientists and manufacturing personnel.
- Manage/Co-manage implementation of new processes/products and exploring new technology in the area of Botulinum toxin product production (both liquid and lyophilized forms) as bioprocess technical expert
- Lead trouble shooting identification and problem solving in process development, during scale up, tech transfer and commercial manufacturing
- Ensure processes are developed, scaled up, transferred from R&D to manufacturing in compliance with all company policies, and cGMPs guidelines
- Identify, define and lead projects to completion with functional, site, business and manufacturing teams
- Participate in process development and tech transfer project, participate in economic evaluation of the projects to allow proper prioritization, participate in evaluation and validation of changes
- Act as a resource to monitor industrial trials (sampling; follow up, gather information)
- Translate and convert process instructions from innovation into company cGMP quality system
- Update bottleneck map and capacity – work within site and project KPIs
- Manage the plant process capability measurement, evaluation programs and troubleshooting actions
Job Qualifications
- Bachelors/Masters of Science or PhD. Degree in Biotechnology, Bio-engineering or chemical engineering
- 3-5 years of relevant work experience in bio process engineering, process development laboratory/Pilot Plant
- Experience in manufacturing of biopharmaceutical products in cGMP environment
- Expertise in manufacturing unit operations especially DP manufacturing unit operations such as formulation, use of single use technologies, freeze drying etc.
- Project management, leadership and mentoring capability.
- Ability to recognize opportunity for improvement, lead change and deliver results.
- Effective communication and time management skills.
- Capability to develop and apply statistical and computer skills.
- Ability to coach influence, negotiate and network with numerous teams as well as work independently when needed.
- Innovation and creativity in problem solving and ability to apply proven methodologies
- Sensitivity for dynamic business needs with the ability to accept and drive organizational change.
- Knowledge and experience of six sigma tools for process improvement
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