Senior Scientist - Chemical Engineer for API Manufacturing Process Development

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Job Overview

The Senior Scientist - Chemical Engineer for API Manufacturing Process Development will play a pivotal role in advancing our manufacturing capabilities through innovative process development. The successful candidate will be responsible for leading projects focused on the development and optimization of Active Pharmaceutical Ingredients (APIs) through the application of chemical engineering principles. This position requires collaboration with cross-functional teams to ensure the translation of laboratory-scale results into viable manufacturing processes, ensuring compliance with regulatory standards and enhancing productivity and efficiency within the manufacturing environment.

Job Responsibilities

• Lead the development and optimization of API manufacturing processes from laboratory scale to production.
• Conduct experiments to evaluate and improve existing processes, ensuring scalability and efficiency.
• Collaborate with R&D teams to support technology transfer and robust process design.
• Analyze data and prepare comprehensive reports to communicate findings and recommendations to stakeholders.
• Ensure all processes comply with regulatory requirements and internal quality standards.
• Identify and implement process improvements through innovative chemical engineering solutions.
• Mentor junior scientists and engineers, fostering a culture of continuous learning and innovation.
• Stay updated on industry trends and advancements in chemical engineering and API development.

Qualifications

• Master’s or Ph.D. in Chemical Engineering, Chemistry, or a related field.
• A minimum of 5 years of experience in API manufacturing or process development within the pharmaceutical industry.
• Strong understanding of chemical engineering principles, thermodynamics, and process modeling.
• Experience with statistical process control and design of experiments (DoE).
• Exceptional analytical and problem-solving skills with a detail-oriented mindset.
• Excellent communication skills, both written and verbal, to effectively convey complex information.
• Proficient in relevant software tools for data analysis and process simulation.

Technologies & Tools

The Senior Scientist will utilize various technologies and tools essential for API process development, including process simulation software such as Aspen Plus or HYSYS, statistical analysis tools such as Minitab, and laboratory equipment for analytical chemistry, including HPLC and GC. Familiarity with software for data management and documentation such as LIMS (Laboratory Information Management System) is essential. Experience with automation tools for process analysis and optimization will be advantageous.

Ideal Candidates

The ideal candidate possesses not only technical proficiency but also strong leadership qualities. They should demonstrate a passion for innovation and a commitment to excellence in the pharmaceutical industry. A proactive mindset paired with the ability to work collaboratively in a team-oriented environment is crucial. Additionally, candidates should exhibit adaptability to evolving challenges and a continuous drive for self-improvement and education in the field, ensuring alignment with the dynamic nature of pharmaceutical development.