Senior Pharmaceutical Process Development Scientist

Placements24; Klerksdorp; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Medical aid

Life cover

Provident fund

Professional development

Annual leave

Job summary

Placements24 in Klerksdorp, North West, invites a Senior Pharmaceutical Process Development Scientist to lead optimization and scale-up of manufacturing processes for new and existing products. You will design, develop, and validate robust processes that meet quality, safety, and regulatory standards in a GMP environment.

The role requires an MSc or PhD in chemical engineering or pharmaceutical sciences, at least five years of process development experience, strong DoE and PAT expertise, and the

Qualifications

• MSc or PhD in Chemical Engineering, Pharmaceutical Sciences, or related field.
• Minimum 5 years of pharmaceutical process development and scale-up experience.
• Strong GMP knowledge and regulatory familiarity (ICH).
• Experience with process validation, technology transfer, and troubleshooting manufacturing issues.
• Proficiency in applying statistical methods, including DoE, for process optimization.

Responsibilities

• Develop and optimize manufacturing processes for pharmaceutical products, ensuring scalability and robustness.
• Conduct process characterization studies and risk assessments to identify CPPs.
• Perform DoE to optimize process performance and define design spaces.
• Lead the scale-up of processes from laboratory to pilot plant and commercial manufacturing scales.
• Develop and validate PAT tools and process analytics.
• Troubleshoot process deviations and implement corrective actions.
• Collaborate with formulation, analytical development, and manufacturing teams.
• Prepare process development reports, validation protocols, and technical transfer documents.
• Ensure all activities comply with GMP, safety, and environmental regulations.
• Mentor junior scientists and contribute to the technical training of staff.

Skills

DoE methods

GMP compliance

Process validation

Technical writing

Team collaboration

Education

MSc or PhD in Chemical Engineering or Pharmaceutical Sciences

Job description

About the Role

A dynamic pharmaceutical company in Klerksdorp, North West , is looking for a Senior Pharmaceutical Process Development Scientist to join their expanding team. This role is crucial for the optimization and scale-up of manufacturing processes for new and existing pharmaceutical products. You will be responsible for designing, developing, and validating robust and efficient manufacturing processes that ensure product quality, safety, and regulatory compliance. The ideal candidate will have a strong foundation in chemical engineering or pharmaceutical sciences, coupled with hands‑on experience in process development within a GMP environment. This position offers an excellent opportunity to contribute to the advancement of pharmaceutical manufacturing technologies in Klerksdorp, North West .

Key Responsibilities

• Develop and optimize manufacturing processes for pharmaceutical products, ensuring scalability and robustness.
• Conduct process characterization studies and risk assessments to identify critical process parameters (CPPs).
• Perform Design of Experiments (DoE) to optimize process performance and define design spaces.
• Lead the scale-up of processes from laboratory to pilot plant and commercial manufacturing scales.
• Develop and validate process analytical technology (PAT) tools.
• Troubleshoot process deviations and implement corrective actions.
• Collaborate with formulation, analytical development, and manufacturing teams.
• Prepare process development reports, validation protocols, and technical transfer documents.
• Ensure all activities comply with GMP, safety, and environmental regulations.
• Mentor junior scientists and contribute to the technical training of staff.

Requirements

• M.Sc. or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 5 years of experience in pharmaceutical process development and scale-up.
• Strong understanding of GMP principles and regulatory requirements (e.g., ICH guidelines).
• Proven experience with process validation, technology transfer, and troubleshooting manufacturing issues.
• Proficiency in applying statistical methods, including DoE, for process optimization.
• Experience with various pharmaceutical manufacturing technologies (e.g., granulation, blending, tableting, sterile processing).
• Excellent analytical, problem-solving, and documentation skills.
• Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
• Experience with PAT is a significant advantage.
• Ability to manage multiple projects simultaneously.

Benefits

The work environment in Klerksdorp, North West , is dynamic and encourages innovation.

• Our client offers a competitive salary and a comprehensive benefits package, including medical aid, life cover, and a provident fund.
• Opportunities for professional development, including attendance at industry conferences and specialized training courses, are provided.
• Generous annual leave and sick leave are standard.

This role presents excellent career growth potential within a growing pharmaceutical organization.