Chemical Engineer - Pharmaceutical Synthesis

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

About the Role

Our client, a rapidly expanding pharmaceutical company, is seeking a highly skilled Chemical Engineer to join their innovative team in Klerksdorp, North West . This role is pivotal in the scale-up, optimization, and validation of chemical synthesis processes for active pharmaceutical ingredients (APIs). The successful candidate will be instrumental in ensuring the efficient, safe, and compliant manufacturing of critical drug components. This position requires a meticulous approach, a strong understanding of organic chemistry principles applied to large-scale production, and expertise in pharmaceutical manufacturing standards. You will collaborate with R&D scientists, quality assurance, and manufacturing teams to drive product development and ensure product integrity. The hybrid model allows for strategic remote engagement combined with essential on-site laboratory and plant activities.

Key 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 Good Manufacturing Practices (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 closely with R&D chemists to transfer new processes efficiently.
• Analyze process data and generate reports on process performance, deviations, and improvement initiatives.
• Work with quality assurance and regulatory affairs to ensure all processes meet stringent pharmaceutical standards.
• Manage process development projects, ensuring timely completion and adherence to budget.

Requirements

• Master's or Ph.D. in Chemical Engineering or Organic Chemistry.
• A minimum of 7 years of experience in chemical process development and scale-up, with a significant focus on pharmaceutical manufacturing or fine chemicals.
• Strong theoretical and practical knowledge of organic synthesis, reaction engineering, and separation technologies.
• Demonstrated experience with GMP, FDA regulations, and validation processes in the pharmaceutical industry.
• Proficiency in process simulation and modeling tools.
• Experience in conducting Process Hazard Analyses (PHAs) and implementing safety measures.
• Excellent analytical, problem-solving, and documentation skills.
• Strong interpersonal and communication skills, vital for collaborative work in a hybrid setting.
• Ability to manage multiple projects and prioritize effectively.
• Residency or willingness to relocate to the Klerksdorp, North West area for on-site responsibilities.

Benefits

Our client offers a competitive compensation package, including excellent medical coverage, a substantial retirement fund contribution, and opportunities for international training and professional growth. We foster an innovative and supportive work environment. The hybrid nature of the role provides flexibility, while the essential on-site work is based in Klerksdorp, North West .