About the Role
Our client, a highly regarded pharmaceutical company specializing in Active Pharmaceutical Ingredient (API) development, is seeking an experienced Principal Process Chemist. This critical role will focus on the design, optimization, and scale-up of chemical synthesis routes for novel drug candidates. Located in Nelspruit, Mpumalanga, this position is office-based, offering hands‑on access to advanced laboratory facilities and close collaboration with a multidisciplinary team of chemists, engineers, and analysts. You will be instrumental in developing robust, efficient, and cost‑effective manufacturing processes for APIs, ensuring compliance with rigorous regulatory standards. The ideal candidate possesses a deep expertise in synthetic organic chemistry, process development, and chemical engineering principles, with a proven ability to translate laboratory‑scale discoveries into viable manufacturing processes.
Key Responsibilities
- Design and develop synthetic routes for APIs, focusing on efficiency, scalability, and safety.
- Optimize reaction conditions, work‑up procedures, and isolation methods for API synthesis.
- Conduct process hazard assessments and implement safety protocols.
- Execute laboratory‑scale experiments and pilot plant runs to demonstrate process feasibility.
- Troubleshoot and resolve technical challenges encountered during process development and scale‑up.
- Collaborate closely with analytical chemists, formulation scientists, and regulatory affairs specialists.
- Ensure all process development activities comply with GMP guidelines and regulatory requirements.
- Prepare detailed process descriptions, technical reports, and documentation for regulatory submissions.
- Mentor junior process chemists and contribute to the strategic direction of process R&D.
Requirements
- PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, or a related field.
- Minimum of 8 years of progressive experience in process chemistry, with a strong focus on API development in the pharmaceutical industry.
- In‑depth knowledge of synthetic organic chemistry, reaction mechanisms, and catalysis.
- Proven experience in process optimization, scale‑up, and technology transfer.
- Familiarity with GMP manufacturing principles and regulatory requirements (e.g., FDA, EMA).
- Hands‑on experience with various analytical techniques for reaction monitoring and product characterization.
- Excellent problem‑solving, communication, and leadership skills.
- Demonstrated ability to manage complex projects and lead cross‑functional teams.
Benefits
- Our client offers a highly competitive salary, an attractive benefits package including comprehensive health insurance, retirement planning, and performance bonuses.
- Employees based in Nelspruit, Mpumalanga benefit from a modern R&D facility, opportunities for professional growth, and exposure to challenging and impactful drug development projects.
- We foster a collaborative and innovative work environment dedicated to advancing pharmaceutical science.
- Join us to make a significant contribution to the development of life‑saving medicines.