Senior Process Development Scientist – API Scale-Up

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

Benefits offered by this job

Competitive salary

Health insurance

Pension fund

Job summary

Placements24 in Vereeniging is seeking a Senior Process Development Scientist to lead API synthesis scale-up and process optimization. You will design experiments, analyze data, and drive efficient manufacture of life-saving medications.

Ideal candidates hold a PhD with 5+ years in pharma process development, understand DOE and regulatory guidelines, and can mentor junior staff while ensuring cGMP compliance and project timelines.

Qualifications

• PhD in a relevant discipline with strong API synthesis and scale-up experience.
• 5+ years hands-on pharmaceutical process development experience.
• Experience with regulatory guidelines (ICH) and cGMP.
• Ability to design and analyze DOE studies and optimise processes.

Responsibilities

• Develop and optimize synthesis routes and purification for APIs and intermediates.
• Conduct lab-scale experiments to explore parameters and define ranges.
• Perform process characterization and validation per regulatory guidelines.
• Scale up from lab to pilot plant and support tech transfer.
• Troubleshoot development and manufacturing process issues.
• Develop in-process controls and release testing methods with QC/QA.
• Prepare technical reports and regulatory submission documents.
• Mentor junior scientists and ensure cGMP compliance.

Skills

DOE expertise

Process development

Scale-up

Education

PhD in Organic Chemistry / Chemical Engineering / Pharmaceutical Sciences

Tools

HPLC

GC

MS

NMR

KF

Design of Experiments (DOE)

Job description

Placements24 in Vereeniging is seeking a Senior Process Development Scientist to lead API synthesis scale-up and process optimization. You will design experiments, analyze data, and drive efficient manufacture of life-saving medications.

Ideal candidates hold a PhD with 5+ years in pharma process development, understand DOE and regulatory guidelines, and can mentor junior staff while ensuring cGMP compliance and project timelines.