Key Responsibilities: • Experiences, knowledge, skill sets, and scientific training in lyophilization in freeze-drying and other related manufacturing processes to support multiple projects to
a) advance process development of pharmaceutical drug products and
b) explore process robustness from lab and pilot to manufacturing scales,
c) characterize and compare the drug products from different manufacturing processes and
d) partner with the project team members and subject matter of experts to deliver project goals timely with high quality.
These include:
Lyophilization Manufacturing Process of Pharmaceutical Products • Support the lab experimental of freeze-dry and other related manufacturing processes, and conduct the lab experiment, analyzed collected data, summarize observations and present slide decks to stakeholders. • Support the scale up of manufacturing process from lab, pilot to commercial scales with cycle developments of various process conditions and cycles for multiple drug products to enhance product quality and improve manufacturability. • Perform engineering analysis by using heat and mass transfer for the lyophilization process and other related manufacturing processes with experiences in different freeze-dryers and support analytical techniques. • Analyze the processing and analytical outcome and provides scientific explanation and justification of results based on the generated data from modeling and analysis. • Characterize the products by multiple analytical instruments to develop the material - equipment - process - performance relationship. • Partners with team members to ensure all objectives are met; supports team to design and develop freeze-drying process of the critical process wetting and product parameters. • Prepare study design and provides written, verbal deliverables, reports and presentations for management and stakeholder reviews during the progress and at the project final conclusion. • Participate in various scientific and technical presentations, discussion, and communication; summarize key observation to support the project team for decision making. • Practice and be aware of the potential consequences (defects and failure modes) of design changes to established processes. Mitigate risk within functions through sound design, early risk assessments and implementation of fallback strategies. • Identify, plan, and conduct medium- to large-size projects across engineering disciplines requiring custom, risk-managed execution plans, investigations, and/or equipment. Make tough decisions regarding priorities between projects.
Expected Qualifications: • Education/degree in Ph.D. or M.S. with lyophilization and related manufacturing processes experience and academic training is preferred and may contribute towards the desired years of experience. • Training at scientific graduate / postgraduate degree in chemical engineering, aeronautics and astronautics engineering, materials science and engineering, mathematical engineering, biomedical engineering, pharmaceutical sciences, physical chemistry, or other relevant degrees. • Experience and knowledge in lyophilization manufacturing process and its related heat transfer (conduction, convection and radiation), mass transfer and momentum transfer of unit operations for scientific problem solving and its associated materials knowledge of the subjects of applications. • Experience and knowledge in process control and monitoring of lyophilization temperature and pressure of drug product manufacturing and advancing in process control and monitoring for continuous improvements.