Lead Biologics Process Development Engineer

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

About the Role

Our client, a prominent player in the global pharmaceutical industry, is seeking an experienced Lead Biologics Process Development Engineer to spearhead innovative projects in Cape Town, Western Cape . This critical role involves the development, optimization, and scale-up of manufacturing processes for novel biologic therapeutics. You will be at the forefront of translating cutting-edge research into viable, large-scale production, ensuring the highest standards of quality and efficiency. The position demands a blend of technical expertise, leadership acumen, and a strategic approach to process engineering challenges. You will work in a state-of-the-art facility, collaborating with a dedicated team of scientists and engineers committed to advancing therapeutic solutions. This is an exceptional opportunity to make a significant impact on patient lives through the reliable supply of life-saving medicines. The successful candidate will be pivotal in shaping the future of biologics manufacturing within South Africa and contributing to our client's global mission.

Key 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.
• Contribute to the strategic planning and roadmap for biologics process development.

Requirements

• 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.
• Demonstrated experience in process scale-up, technology transfer, and GMP manufacturing environments.
• Strong understanding of bioreactor operation, cell culture, and/or protein purification principles.
• Expertise in process characterization, validation, and regulatory filing support.
• Proven ability to lead technical teams and manage complex projects from concept to completion.
• Excellent problem-solving, analytical, and critical thinking skills.
• Outstanding communication and interpersonal skills, with the ability to effectively engage with diverse stakeholders.
• Proficiency in using process simulation and statistical analysis software (e.g., JMP, SuperPro Designer).
• Experience with single-use technologies is a plus.

Benefits

Our client offers a highly competitive salary package, complemented by comprehensive health and dental insurance, a generous retirement annuity contribution, and opportunities for career advancement. Employees have access to ongoing professional development programs, a dynamic and collaborative work environment, and the chance to contribute to cutting-edge advancements in medicine. We also provide paid vacation days, an annual bonus scheme, and access to state-of-the-art facilities in Cape Town . This role is based on-site to ensure the close collaboration and hands-on work required for process development.