Pharma Synthesis Engineer - GMP Scale-Up | Hybrid Role

Placements24; United States; Hybrid; USD 71,000 - 95,000; Full time

Benefits offered by this job

Medical coverage

Retirement fund

International training

Hybrid work model

Job summary

Placements24 is assisting a rapidly expanding pharmaceutical company in finding a highly skilled Chemical Engineer to lead scale-up, optimization, and validation of API synthesis in Klerksdorp, North West. The role combines on-site lab work with strategic remote engagement within a hybrid model.

The candidate will require an advanced degree and at least 7 years of experience in pharmaceutical process development, with strong organic chemistry knowledge and GMP/FDA experience.

Qualifications

• Master's or Ph.D. in Chemical Engineering or Organic Chemistry.
• Minimum 7 years of experience in chemical process development and scale-up in pharma or fine chemicals.
• Strong knowledge of organic synthesis, reaction engineering, and separation technologies.
• Experience with GMP, FDA regulations, and validation in the pharmaceutical industry.
• Proficiency in process simulation and modeling tools.
• Experience conducting PHAs and implementing safety measures.
• Excellent analytical, problem-solving, and documentation skills.
• Strong interpersonal and communication skills for hybrid collaboration.
• Ability to manage multiple projects and prioritize effectively.
• Residency or willingness to relocate to Klerksdorp, North West for on-site responsibilities.

Responsibilities

• Lead the scale-up of laboratory chemical synthesis routes to pilot and commercial production scales.
• Optimize existing synthesis processes for improved yield, purity, safety, and cost-effectiveness.
• Develop and validate new chemical processes in compliance with GMP.
• Troubleshoot process-related issues and implement robust solutions.
• Conduct process hazard analyses (PHAs) and ensure compliance with safety regulations.
• Prepare detailed process documentation, including batch records, SOPs, and validation reports.
• Collaborate with R&D chemists to transfer new processes efficiently.
• Analyze process data and generate reports on process performance, deviations, and improvement initiatives.
• Work with QA and regulatory to ensure processes meet pharmaceutical standards.
• Manage process development projects, ensuring timely completion and adherence to budget.

Skills

Process optimization

Scale-up experience

GMP knowledge

PHAs experience

Documentation skills

Education

MSc/PhD in Chemical Eng or Organic Chem

Tools

Process simulation software

Job description

Placements24 is assisting a rapidly expanding pharmaceutical company in finding a highly skilled Chemical Engineer to lead scale-up, optimization, and validation of API synthesis in Klerksdorp, North West. The role combines on-site lab work with strategic remote engagement within a hybrid model.

The candidate will require an advanced degree and at least 7 years of experience in pharmaceutical process development, with strong organic chemistry knowledge and GMP/FDA experience.