Senior Process Chemist - Scale-Up & Optimization

About the Role

Our client, a prominent pharmaceutical manufacturer, is seeking a highly experienced Senior Process Chemist to join their dedicated Process Development team in Polokwane, Limpopo . This critical role focuses on the scale-up, optimization, and validation of chemical synthesis processes for active pharmaceutical ingredients (APIs). You will be instrumental in translating laboratory-scale procedures into robust, efficient, and safe manufacturing processes suitable for commercial production. The ideal candidate will possess a deep understanding of organic synthesis, reaction kinetics, process safety, and analytical method development. This is an excellent opportunity to contribute to the production of life-saving medicines within a well-established, quality-driven organization in Polokwane . You will work with state-of-the-art equipment and collaborate with a multidisciplinary team of chemists, engineers, and quality assurance professionals.

Key Responsibilities

• Develop and optimize synthetic routes for APIs, focusing on yield improvement, cost reduction, and impurity profiling.
• Lead process scale-up activities from laboratory to pilot plant and commercial manufacturing scales.
• Conduct thorough process hazard analyses (PHAs) and implement necessary safety controls.
• Develop and validate analytical methods (e.g., HPLC, GC, KF) to monitor reaction progress and product quality.
• Investigate and resolve process deviations and deviations from established manufacturing procedures.
• Collaborate with engineering teams to design and implement process improvements and new equipment.
• Prepare detailed process documentation, including Batch Manufacturing Records (BMRs) and technical reports.
• Ensure all process development activities comply with cGMP guidelines and regulatory requirements.
• Mentor junior process chemists and provide technical guidance.
• Stay current with advancements in process chemistry, engineering, and pharmaceutical manufacturing technologies.

Requirements

• Ph.D. or Master's degree in Organic Chemistry, Process Chemistry, or Chemical Engineering.
• A minimum of 8 years of experience in process development and scale-up within the pharmaceutical or fine chemical industry.
• Strong expertise in synthetic organic chemistry and reaction mechanism understanding.
• Proven experience with process safety assessments and hazard mitigation.
• Proficiency in analytical techniques relevant to pharmaceutical process monitoring.
• Familiarity with cGMP regulations and quality systems in pharmaceutical manufacturing.
• Demonstrated ability to troubleshoot complex process issues.
• Excellent project management and organizational skills.
• Strong written and verbal communication skills, with the ability to document work clearly and concisely.
• Experience with Design of Experiments (DoE) methodologies is a plus.

Benefits

This position offers a competitive salary package, regular performance reviews, and a comprehensive benefits program including health insurance, a pension fund, and substantial annual leave. Our client is committed to employee development and provides opportunities for continuous training, professional certifications, and attendance at industry conferences. The work environment in Polokwane is professional, safety-conscious, and focused on delivering high-quality pharmaceutical products. Join a stable and reputable company where your expertise in process chemistry will be highly valued and contribute directly to the success of critical drug manufacturing initiatives.

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