Senior Process Development Scientist - Pharmaceutical

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

About the Role

Our client, a distinguished pharmaceutical company, is seeking a highly experienced Senior Process Development Scientist to join their innovative research and development team in Vereeniging, Gauteng. This role is critical for the optimization and scale-up of pharmaceutical manufacturing processes. You will be responsible for designing, executing, and analyzing experiments aimed at improving product yield, purity, and overall process efficiency. The position offers a chance to work with cutting-edge technology and contribute to the development of life-saving medications. We are looking for a meticulous and driven scientist passionate about pharmaceutical process innovation and based in or willing to relocate to Vereeniging, Gauteng.

Key Responsibilities

• Develop and optimize robust chemical synthesis routes and purification methods for active pharmaceutical ingredients (APIs) and intermediates.
• Design and execute laboratory-scale experiments to investigate process parameters, identify critical process attributes, and define operating ranges.
• Perform process characterization and validation studies in accordance with regulatory guidelines (e.g., ICH).
• Scale up processes from laboratory to pilot plant and ultimately to commercial manufacturing, ensuring seamless technology transfer.
• Troubleshoot and resolve process-related issues encountered during development and manufacturing phases.
• Develop analytical methods for in-process control and final product release testing, collaborating with QC/QA departments.
• Prepare detailed technical reports, study protocols, and regulatory submission documents.
• Stay current with scientific literature, new technologies, and best practices in pharmaceutical process development.
• Mentor and provide technical guidance to junior scientists and technicians within the process development team.
• Ensure all activities are conducted in compliance with cGMP regulations and company safety policies.

Requirements

• PhD in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline.
• A minimum of 5 years of hands-on experience in pharmaceutical process development, with a strong emphasis on API synthesis and scale-up.
• Demonstrated expertise in process chemistry, reaction kinetics, and separation techniques.
• Experience with analytical techniques such as HPLC, GC, MS, NMR, and KF is essential.
• Proven ability to design and execute DOE (Design of Experiments) studies.
• Knowledge of cGMP regulations and ICH guidelines pertinent to process development and validation.
• Excellent problem-solving skills, attention to detail, and ability to work independently and in a team environment.
• Strong written and verbal communication skills, with the ability to clearly document and present scientific findings.
• Experience in preparing CMC sections for regulatory filings is a significant advantage.
• Must be located in or willing to relocate to Vereeniging, Gauteng.

Benefits

• Competitive annual salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off, including vacation, sick leave, and holidays.
• Opportunities for professional growth, training, and conference attendance.
• Access to state-of-the-art laboratory facilities and equipment.
• A collaborative and scientifically driven work environment.
• Pension fund and life assurance benefits.
• Potential for career advancement within a leading pharmaceutical organization.