R&D Scientist - Purification and Isolation of Active Pharmaceutical Ingredients (APIs)

R&D Scientist - Purification and Isolation of Active Pharmaceutical Ingredients (APIs)

• Conduct in-depth literature reviews to stay abreast of the latest advancements in purification and isolation techniques.
• Design and execute experiments to develop novel methods for the purification and isolation of APIs.
• Collaborate with cross-functional teams to integrate purification processes into the overall drug development strategy.
• Optimize existing purification processes to improve efficiency, yield, and purity of APIs.
• Scale-up laboratory processes for potential transfer to manufacturing, ensuring scalability and reproducibility.
• Utilize a variety of analytical techniques, such as HPLC, GC and mass spectrometry, to characterize and assess the quality of isolated APIs.
• Collaborate with analytical scientists to develop and implement methods for real-time monitoring of purification processes.
• Develop and implement quality control measures to ensure the consistent production of APIs meeting regulatory and quality standards.
• Investigate and address any deviations or discrepancies in the purification process.
• Maintain detailed and accurate records of experimental procedures, results, and conclusions.
• Prepare technical reports and documentation for internal and external stakeholders.
• Stay informed about regulatory guidelines and ensure that all purification and isolation processes comply with relevant regulatory requirements.
• Ph.D. in Chemistry, Pharmaceutical Sciences, or a related field with a focus on organic synthesis and purification.
• Proven experience in the purification and isolation of pharmaceutical compounds, preferably with a background in API development.
• Strong knowledge of chromatography, crystallization, and other purification techniques.
• Familiarity with analytical techniques used in pharmaceutical research.
• Excellent problem-solving skills and ability to troubleshoot and optimize processes.
• Effective communication and collaboration skills.

• Experience with process scale-up and technology transfer to manufacturing.
• Familiarity with Good Manufacturing Practices (GMP) and regulatory requirements.
• Ability to work independently and as part of a multidisciplinary team.
• Strong project management skills.