Job Summary (Primary function)
Essential Functions of the Job (Key responsibilities)
·Conduct process analysis, simplification and intensification for APIs and their intermediates.
·Plan how to move laboratory synthetic procedures into a pilot production phase, then onto large-scale industrial processing.
·Develop methods to deal with by-products and waste materials in a safe and environmentally friendly way.
·Design experiments and procedures that will identify and solve engineering issues in process development and production.
·Work with selected CMOs in the selection, usage and optimization of the equipment trail based on chemistry and batch requirements.
·Help to oversee the day-to-day operation at the selected CMOs’ plant.
·Monitor production status at the selected CMOs’ plant and deal with issues.
·Work closely with CMOs’ health and safety managers to ensure the safe manufacturing process.
·Work closely with internal and external QC and QA functions to ensure each batch of the high-quality APIs is manufactured and delivered on time.
·Perform non-routine project work as assigned, make cost effective recommendations and proactively seek out senior managers to discuss solutions and project strategy.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·B. Sc., M.Sc. Or Ph. D. in Chemical Engineering required.
·Minimum level of experience of Ph.D.: 0 years; M.Sc: 2 years; B.Sc.: 5 years of industrial experience involving research and development of API processes and manufacture of investigational and commercial drugs.
·Background working with process chemists and understanding the importance of the development of high-quality and cost-effective small molecular processes that result in more medicines reaching a greater number of patients.
·Demonstrated understanding of chemical process development and API manufacturing to adopt at designing processes based on plant equipment, reaction kinetics, hazard analysis and physical and thermodynamic data.
·Travel 10-25%
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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