Chemical Engineer - Pharmaceutical Process Development

Placements24; Soweto; Hybrid; ZAR 551,000 - 1,033,000; Full time

Benefits offered by this job

Remote contract position

Flexible remote work

Job summary

Placements24 is seeking an experienced Chemical Engineer for a remote contract role focused on Pharmaceutical Process Development. You will design, optimize, and scale manufacturing processes for new API products, collaborating with R&D, formulation, and QA teams to ensure robust, compliant processes.

The role involves scaling from lab to pilot and commercial manufacturing, defining CPPs/CQAs, and developing validation strategies in a global pharma setting.

Qualifications

• Master's or PhD in Chemical Engineering required.
• 7+ years in pharmaceutical process development and scale-up.
• Strong understanding of organic synthesis, reaction engineering, and separationTechniques in pharma.
• Experience with GMP requirements and quality by design (QbD).

Responsibilities

• Develop and optimize synthesis and manufacturing processes for APIs and intermediates.
• Scale up from lab to pilot plant and to commercial manufacturing.
• Conduct process characterization studies and risk assessments (e.g., FMEA).
• Define CPPs and CQAs for manufacturing processes.
• Develop process validation strategies and support execution.
• Troubleshoot process-related issues in development and manufacturing.
• Collaborate with regulatory affairs to ensure GMP compliance.
• Author and review process descriptions, validation protocols, and reports.
• Evaluate and implement new process technologies and analytical methods.

Skills

Process development

Scale-up

GMP compliance

Project management

Remote collaboration

Education

Master's degree in Chemical Engineering

PhD in Chemical Engineering

Tools

Process simulation software

Statistical analysis tools

Job description

About the Role

Our client, a renowned pharmaceutical company with a strong global presence, is seeking an experienced Chemical Engineer for a remote Contractor role focused on Pharmaceutical Process Development. This position is crucial for designing, optimizing, and scaling up manufacturing processes for new pharmaceutical products. You will work with cross-functional teams, including R&D scientists, formulation specialists, and quality assurance, to ensure robust, efficient, and compliant processes are established. This remote role offers the flexibility to work from anywhere while contributing to life-saving medicines.

Key Responsibilities

• Develop and optimize chemical synthesis and manufacturing processes for pharmaceutical active ingredients (APIs) and intermediates.
• Scale up processes from laboratory bench to pilot plant and commercial manufacturing.
• Conduct process characterization studies and risk assessments (e.g., FMEA).
• Define critical process parameters (CPPs) and critical quality attributes (CQAs) for manufacturing processes.
• Develop process validation strategies and support their execution.
• Troubleshoot and resolve process-related issues during development and commercial manufacturing.
• Collaborate with regulatory affairs to ensure processes meet GMP and other relevant guidelines.
• Author and review technical documents, including process descriptions, validation protocols, and reports.
• Evaluate and implement new process technologies and analytical methods.

Requirements

• Master's degree or PhD in Chemical Engineering.
• Minimum of 7 years of experience in process development and scale-up within the pharmaceutical industry.
• Strong understanding of organic synthesis, reaction engineering, and separation techniques in a pharmaceutical context.
• Proven experience with GMP (Good Manufacturing Practice) requirements.
• Experience with process validation, QbD (Quality by Design) principles, and risk management tools.
• Proficiency in process simulation software and statistical analysis tools is a plus.
• Excellent communication, collaboration, and project management skills, especially in a remote setting.
• Ability to work independently and manage multiple projects simultaneously.
• Familiarity with analytical techniques used in pharmaceutical quality control.

Benefits

This is a remote contractor position offering a highly competitive daily or hourly rate, commensurate with experience and expertise. Our client provides exposure to cutting-edge pharmaceutical development projects and the opportunity to contribute significantly to bringing new therapies to patients. Enjoy the flexibility of a remote work arrangement. Join a leading pharmaceutical innovator and advance your career in process development.