Bioprocess Engineer

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