Global Manufacturing Engineer - API/Small Molecule

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Written by AI from the job title and company, not by Telix Pharmaceuticals Limited, so some details may not match this job. The employer's own page has the real description.

Overview

The Global Manufacturing Engineer - API/Small Molecule at Telix Pharmaceuticals Limited will play a crucial role in the development, optimization, and scaling of manufacturing processes for active pharmaceutical ingredients (API) and small molecules. This position requires a combination of technical expertise, project management skills, and a collaborative mindset to ensure that manufacturing processes are efficient, compliant, and aligned with regulatory standards. The successful candidate will work closely with cross-functional teams, including R&D, Quality Assurance, and Production, to drive process improvements and enhance product quality throughout the manufacturing lifecycle.

Job Responsibilities

• Design and optimize manufacturing processes for API and small molecule products.
• Conduct process risk assessments and implement control strategies to mitigate potential issues.
• Develop and execute scale-up protocols for production processes.
• Collaborate with cross-functional teams to ensure integration of manufacturing processes with product development activities.
• Support regulatory submissions and inspections by providing necessary documentation and technical expertise.
• Monitor manufacturing performance and drive continuous improvement initiatives.
• Evaluate new technologies and methodologies to enhance manufacturing efficiency and product quality.
• Provide training and support to manufacturing personnel on new processes and technologies.

Qualifications

• Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, or a related field; a Master's degree is a plus.
• Minimum of 5 years of experience in pharmaceutical manufacturing engineering, particularly in API and small molecule production.
• Strong knowledge of GMP (Good Manufacturing Practices) regulations and quality systems.
• Proven experience in process optimization and scale-up methodologies.
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Strong communication and interpersonal skills for effective collaboration across teams.
• Ability to manage multiple projects and tasks in a fast-paced environment.

Technologies & Tools

The Global Manufacturing Engineer will utilize advanced manufacturing software and tools to monitor and manage production processes. Key technologies include process simulation software, statistical process control (SPC) tools, and electronic laboratory notebooks (ELN). Proficiency in tools such as Design of Experiments (DoE) software and data analysis tools is also essential for enhancing manufacturing efficiency and product quality.

Ideal Candidates

Ideal candidates for this position possess a strong technical background coupled with excellent analytical capabilities and a passion for pharmaceutical manufacturing. They are proactive problem-solvers who can think critically and adapt to evolving challenges in a dynamic work environment. Successful candidates demonstrate effective collaboration skills, enabling them to work seamlessly with diverse teams, while also showcasing a commitment to compliance and quality assurance in all manufacturing operations.