About the Role
Our client, a cutting-edge biopharmaceutical company, is looking for a talented Biopharmaceutical Process Engineer to join their team in Randburg, Gauteng. This role is pivotal in the design, development, optimization, and scale-up of manufacturing processes for biopharmaceutical products, including monoclonal antibodies and recombinant proteins. You will apply engineering principles and scientific knowledge to ensure robust, efficient, and compliant bioprocessing operations. The ideal candidate has a strong understanding of cell culture, fermentation, purification, and downstream processing technologies. This is a hybrid position, requiring regular on-site work in our state-of-the‑art facilities for hands‑on process development and troubleshooting, combined with remote opportunities for data analysis, reporting, and strategic planning. We are committed to advancing biotechnology to improve patient outcomes.
Key Responsibilities
- Design, develop, and optimize upstream and downstream bioprocesses for the manufacturing of biopharmaceuticals.
- Scale‑up processes from laboratory to pilot plant and commercial manufacturing scales.
- Troubleshoot and resolve process‑related issues to ensure consistent product quality and yield.
- Conduct process characterization studies and define critical process parameters (CPPs).
- Develop and implement process control strategies.
- Prepare process descriptions, validation protocols, and reports for regulatory submissions.
- Collaborate with cross‑functional teams, including R&D, Manufacturing, Quality Assurance, and Project Management.
- Stay current with emerging technologies and industry best practices in biopharmaceutical manufacturing.
- Ensure all process activities comply with GMP regulations and internal quality standards.
- Perform process simulations and modeling to evaluate process performance and identify optimization opportunities.
Requirements
- Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
- A minimum of 5 years of experience in biopharmaceutical process development and scale‑up.
- In-depth knowledge of upstream (e.g., cell culture, fermentation) and downstream (e.g., chromatography, filtration) bioprocessing unit operations.
- Experience with mammalian cell culture, microbial fermentation, or protein purification is essential.
- Familiarity with GMP regulations and guidelines relevant to biopharmaceutical manufacturing.
- Strong analytical, problem‑solving, and critical thinking skills.
- Excellent written and verbal communication skills, with the ability to present technical information effectively.
- Proficiency in process modeling software (e.g., Aspen, gPROMS) is a plus.
- Ability to work effectively in a hybrid environment, balancing on‑site and remote tasks.
- Team player with strong collaboration skills.
Benefits
- Competitive annual salary of ZAR.
- Comprehensive health, dental, and vision insurance.
- Generous retirement savings plan.
- Significant opportunities for professional development and career growth.
- Hybrid work model offering flexibility.
- Access to advanced biomanufacturing facilities and technologies.
- Collaborative and innovative work culture.
- Performance‑based bonuses and stock options.