Senior Biologics Process Development Lead — Cape Town

Placements24; Cape Town; On-site; ZAR 1,800,000 - 3,000,000; Full time

Benefits offered by this job

Health and dental insurance

Retirement annuity

Annual bonus

Professional development

On-site Cape Town facility

Job summary

Placements24 seeks a Lead Biologics Process Development Engineer in Cape Town to spearhead development and scale-up of biologics manufacturing processes. You will drive upstream/downstream optimization, pilot studies, and technology transfer with cross-functional teams focused on quality and efficiency.

The role demands 7+ years in biologics development, strong leadership, and expertise in cell culture, purification, and GMP environments.

Qualifications

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 7 years of progressive experience in biologics process development and manufacturing.
• Proven ability to lead technical teams and manage complex projects from concept to completion.

Responsibilities

• Lead the development and optimization of upstream and downstream processes for biologics manufacturing (e.g., cell culture, fermentation, purification).
• Design and execute pilot-scale and manufacturing validation studies.
• Develop process models and conduct statistical analysis to understand and control process variability.
• Troubleshoot and resolve complex technical issues encountered during process development and scale-up.
• Author and review technical reports, protocols, and regulatory submissions (e.g., IND, BLA sections).
• Manage and mentor a team of process development engineers and scientists, fostering technical growth and project execution.
• Collaborate with manufacturing operations, quality assurance, and regulatory affairs teams to ensure seamless technology transfer.
• Evaluate and implement new technologies to enhance process efficiency, robustness, and cost-effectiveness.
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory requirements.

Skills

Biologics processing

GMP manufacturing

Process scale-up

Leadership

Statistical analysis

Regulatory filing support

Education

Master's or Ph.D. in Chemical/Biochemical Engineering or Biotechnology

Tools

JMP

SuperPro Designer

Job description

Placements24 seeks a Lead Biologics Process Development Engineer in Cape Town to spearhead development and scale-up of biologics manufacturing processes. You will drive upstream/downstream optimization, pilot studies, and technology transfer with cross-functional teams focused on quality and efficiency.

The role demands 7+ years in biologics development, strong leadership, and expertise in cell culture, purification, and GMP environments.