Senior Process Development Scientist

Placements24; Benoni; On-site; ZAR 1,200,000 - 1,800,000; Full time

Job summary

Placements24 is seeking a Senior Process Development Scientist for its Benoni, Gauteng labs and pilot plant. The role focuses on optimizing and scaling manufacturing processes for APIs and drug candidates, requiring hands-on work in a state-of-the-art facility.

The ideal candidate holds a PhD in Organic Chemistry or Chemical Engineering with at least 6 years in pharmaceutical process development, including scale-up, PAT/SPC proficiency, and strong regulatory knowledge.

Qualifications

• PhD in Organic Chemistry, Chemical Engineering, or a related field.
• Minimum of 6 years of process development experience in pharmaceutical or fine chemical industry.
• Strong understanding of synthetic organic chemistry and reaction mechanisms.
• Proven experience in process scale-up from lab to pilot plant.
• Proficiency in process analytical technology (PAT) and statistical process control (SPC).
• Experience with process safety evaluations and risk assessments.
• Familiarity with GMP requirements and regulatory submission processes.
• Excellent problem-solving, analytical and project management skills.
• Strong written and verbal communication skills.
• Ability to work on-site in Benoni, Gauteng.

Responsibilities

• Design, develop, and optimize chemical processes for synthesis of APIs and intermediates.
• Perform process characterization studies to understand critical process parameters.
• Develop and validate analytical methods for monitoring process performance and product quality.
• Conduct process safety assessments and implement control measures.
• Lead technology transfer from R&D to pilot plant and manufacturing sites.
• Troubleshoot process issues and improve yield, purity, and efficiency.
• Collaborate with formulation, analytical development, and manufacturing teams.
• Write detailed process development reports, batch records, and regulatory documents.
• Ensure compliance with GMP, ICH and related guidelines.
• Mentor junior scientists and engineers in process development.

Education

PhD in Organic Chemistry or Chemical Engineering

Tools

PAT

SPC

Job description

About the Role

Our client, a cutting-edge pharmaceutical research organization located in Benoni, Gauteng, is seeking a highly skilled Senior Process Development Scientist. This role is central to the optimization and scale-up of manufacturing processes for novel drug candidates. The ideal candidate will possess a robust understanding of chemical engineering principles, process chemistry, and analytical techniques, with a proven ability to translate laboratory-scale processes to pilot and commercial production. You will be instrumental in ensuring efficient, safe, and cost-effective manufacturing of APIs and drug products. This is an on-site role, requiring significant hands-on work within our Benoni development laboratories and pilot plant facilities.

Key Responsibilities

• Design, develop, and optimize chemical processes for the synthesis of pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
• Perform process characterization studies to understand critical process parameters and their impact on product quality.
• Develop and validate analytical methods for monitoring process performance and product quality.
• Conduct process safety assessments and implement appropriate control measures.
• Lead technology transfer activities from R&D labs to pilot plant and manufacturing sites.
• Troubleshoot process issues and implement solutions to improve yield, purity, and efficiency.
• Collaborate closely with formulation development, analytical development, and manufacturing teams.
• Write detailed process development reports, batch records, and regulatory submission documents.
• Ensure compliance with all relevant regulatory guidelines (e.g., GMP, ICH).
• Mentor and guide junior scientists and engineers in process development activities.

Requirements

• PhD in Organic Chemistry, Chemical Engineering, or a related field.
• Minimum of 6 years of experience in process development within the pharmaceutical or fine chemical industry.
• Strong understanding of synthetic organic chemistry and reaction mechanisms.
• Proven experience in process scale-up, from laboratory to pilot plant.
• Proficiency in process analytical technology (PAT) and statistical process control (SPC).
• Experience with process safety evaluations and risk assessments.
• Familiarity with GMP requirements and regulatory submission processes.
• Excellent problem-solving, analytical, and project management skills.
• Strong written and verbal communication skills.
• Ability to work collaboratively in a team environment and commit to on-site work in Benoni, Gauteng.

Benefits

• Our client offers a competitive salary, comprehensive health and wellness benefits, and a generous retirement savings plan.
• Opportunities for continuous professional development, including training and conference attendance, are provided.
• You will be working in a state-of-the-art facility in Benoni, contributing to the advancement of life-saving medicines.
• Join a dedicated team focused on innovation and excellence in pharmaceutical development.