Lead Bioprocess Engineer

Placements24; South Africa; Remoto; ZAR 1.000.000 - 1.600.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus program

Health insurance

Paid leave

Professional development

Cutting-edge technology

Descrizione del lavoro

Placements24 is seeking a seasoned Lead Bioprocess Engineer to spearhead development and scale-up of biologics at their state-of-the-art facilities in Tembisa. You will oversee upstream/downstream operations, ensure GMP compliance, and drive process improvements to deliver high-quality products.

The role requires 7+ years in biopharma, advanced degree in engineering or biotechnology, and strong leadership with collaboration across QA, regulatory, and analytics teams.

Competenze

• Master’s or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• 7+ years in biopharma with process development and scale-up.
• Experience in mammalian cell culture, fermentation, and purification technologies.
• Experience with GMP and regulatory concepts.

Mansioni

• Lead development and optimization of large-scale bioprocesses (upstream and downstream).
• Design pilot-scale studies and manufacturing validation to ensure robustness.
• Troubleshoot technical issues affecting process performance and quality.
• Develop control strategies and ensure GMP adherence.
• Collaborate with QA, regulatory, and analytics teams on development and filings.
• Mentor bioprocess engineers and technicians in a fast-paced environment.

Conoscenze

Leadership

Bioprocess development

Scale-up expertise

GMP compliance

Regulatory knowledge

Cell culture/Mammalian

Fermentation/Purification

Process modeling

Statistical analysis

Project management

Formazione

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

Strumenti

Aspen Plus

MATLAB/R

Process modeling software

Descrizione del lavoro

About the Role

Our client is seeking a seasoned Lead Bioprocess Engineer to spearhead critical development initiatives within their state-of-the-art facilities in Tembisa . This senior position involves overseeing the design, optimization, and scale-up of biological manufacturing processes for novel therapeutics. You will play a key role in ensuring process efficiency, product quality, and regulatory compliance. This is an exciting opportunity for a leader in bioprocessing to make a significant impact on the production of life-saving products, working collaboratively with a talented team of scientists and engineers in a forward-thinking research and development environment.

Key Responsibilities

• Lead the development and optimization of large-scale bioprocesses , including upstream (cell culture/fermentation) and downstream (purification) operations.


• Design and execute pilot-scale and manufacturing validation studies to ensure process robustness and reproducibility.


• Troubleshoot and resolve complex technical issues related to process performance, equipment, and product quality.


• Develop and implement process control strategies and ensure adherence to Good Manufacturing Practices (GMP).


• Collaborate with analytical development, quality assurance, and regulatory affairs teams to support product development and submission activities.


• Mentor and guide a team of bioprocess engineers and technicians, fostering a culture of continuous improvement and technical excellence in Tembisa .

Requirements

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.


• Minimum of 7 years of experience in the biopharmaceutical industry, with a focus on process development and scale-up.


• Proven expertise in mammalian cell culture, microbial fermentation, and/or protein purification technologies.


• Demonstrated experience with process modeling, simulation, and statistical analysis tools.


• Strong understanding of regulatory guidelines (FDA, EMA) and quality systems.


• Excellent leadership, project management, and communication skills, with experience managing technical teams.

Benefits

• Highly competitive salary and performance-based bonus structure.


• Comprehensive health, dental, and vision insurance plans.


• Generous annual leave and paid public holidays.


• Professional development opportunities, including advanced training and conference participation.


• A dynamic and innovative work environment with cutting-edge technology in Gauteng .