Senior Pharmaceutical Process Chemist

Placements24; Stellenbosch; Hybrid; ZAR 1,000,000 - 1,300,000; Full time

Benefits offered by this job

Hybrid work model

Medical aid

Retirement fund

Life insurance

Annual leave

Job summary

Placements24 is seeking a Senior Pharmaceutical Process Chemist for a Paarl-based API development operation. The role focuses on developing, optimizing, and scaling synthesis routes for active pharmaceutical ingredients, with emphasis on safety, quality, and regulatory compliance.

You will lead laboratory and pilot-plant activities, collaborate across R&D, analytical, and manufacturing, and implement DoE and PAT approaches to improve process performance.

Qualifications

• Ph.D. or Master’s in Organic Chemistry, Process Chemistry, or related field.
• Minimum of 6 years in pharmaceutical process chemistry and API development.
• Strong knowledge of organic synthesis, reaction mechanisms, and catalysis.

Responsibilities

• Design, develop, and optimize synthetic routes for APIs suitable for large-scale manufacturing.
• Conduct lab experiments to explore new methodologies and improve processes.
• Perform process characterization studies including kinetics and impurity profiling.
• Develop and validate analytical methods for monitoring intermediates and APIs.
• Scale up processes from lab to pilot plant and commercial scale, ensuring safety and efficiency.
• Troubleshoot process issues, identify root causes, and implement corrective actions.
• Prepare detailed development reports, batch records, and validation documentation.
• Ensure GMP, environmental regulations, and safety compliance; collaborate with R&D, analytical, engineering, and manufacturing.

Skills

Organic synthesis

Process chemistry

Scale-up

DoE

PAT

Data analysis

Education

PhD or MSc in Organic/Process Chemistry

Tools

HPLC

GC

NMR

MS

XRPD

Job description

About the Role

Our client, a reputable pharmaceutical manufacturing company located in Paarl, Western Cape , is seeking an experienced Senior Pharmaceutical Process Chemist to join their expanding operations. This vital role focuses on the development, optimization, and scale-up of chemical synthesis processes for active pharmaceutical ingredients (APIs). You will ensure that manufacturing processes are safe, efficient, cost-effective, and compliant with all regulatory standards. This hybrid position involves significant laboratory and pilot plant work, balanced with remote data analysis and documentation. The ideal candidate will possess a strong background in organic synthesis and process chemistry, with a proven track record in the pharmaceutical industry. This is an excellent opportunity to lead critical chemical development projects and contribute to the supply of essential medicines.

Key Responsibilities

• Design, develop, and optimize synthetic routes for Active Pharmaceutical Ingredients (APIs) suitable for large-scale manufacturing.
• Conduct laboratory experiments to explore new synthetic methodologies and improve existing processes.
• Perform process characterization studies, including reaction kinetics, thermodynamics, and impurity profiling.
• Develop and validate analytical methods for monitoring process intermediates and APIs.
• Scale up chemical processes from laboratory bench to pilot plant and commercial scale, ensuring safety and efficiency.
• Troubleshoot process-related issues, identifying root causes and implementing corrective actions.
• Author detailed process development reports, batch records, and validation documentation.
• Ensure compliance with Good Manufacturing Practices (GMP), environmental regulations, and safety protocols.
• Collaborate with cross-functional teams including R&D, analytical, engineering, and manufacturing.
• Evaluate and implement new process technologies and equipment.

Requirements

• Ph.D. or Master's degree in Organic Chemistry, Process Chemistry, or a related field.
• Minimum of 6 years of experience in pharmaceutical process chemistry and API development.
• Strong theoretical and practical knowledge of organic synthesis, reaction mechanisms, and catalysis.
• Proven experience in process scale-up and troubleshooting of chemical reactions.
• Familiarity with analytical techniques relevant to API characterization (e.g., HPLC, GC, NMR, MS, XRPD).
• Understanding of GMP, process safety, and environmental regulations.
• Excellent problem-solving skills, with a keen eye for detail and data analysis.
• Strong project management capabilities and the ability to lead technical teams.
• Effective written and verbal communication skills, with the ability to present technical information clearly.
• Experience with Design of Experiments (DoE) and Process Analytical Technology (PAT) is advantageous.

Benefits

Our client offers a competitive salary, bonus potential, and comprehensive benefits including medical aid, retirement fund contributions, and life insurance. The hybrid work model allows for flexibility. Generous paid time off, including annual leave and sick leave, is provided. Opportunities for professional growth through training, conferences, and further education are available. The company promotes a collaborative and innovative work environment. Employees benefit from a focus on safety and quality.