About the Role
Our client, a biotechnology firm at the forefront of developing novel biopharmaceuticals, is seeking a highly experienced Senior Chemical Engineer specializing in Downstream Processing. This role, based in Port Elizabeth, Eastern Cape , will be instrumental in designing, optimizing, and scaling up purification processes for biologics. You will work with cutting-edge technologies to ensure the highest purity and yield of therapeutic products. This is an exciting opportunity to join a rapidly growing company with a strong pipeline and a commitment to innovation. The position involves close collaboration with R&D, analytical, and manufacturing teams to translate laboratory-scale purification methods into robust, commercial-scale operations. We are looking for a motivated individual who thrives in a challenging and rewarding environment.
Key Responsibilities
- Design, develop, and optimize downstream processing trains for biologics, including chromatography, filtration, and viral inactivation steps.
- Scale-up purification processes from laboratory to pilot and commercial manufacturing scales.
- Develop and validate purification methods in accordance with regulatory guidelines (e.g., GMP).
- Troubleshoot and resolve technical issues related to downstream processing equipment and operations.
- Perform process modeling and simulation to predict performance and identify optimization opportunities.
- Write detailed process descriptions, URS, FRS, and execution protocols.
- Collaborate with cross-functional teams to ensure successful technology transfer and process implementation.
- Stay updated on industry trends and advancements in biopharmaceutical downstream processing.
- Contribute to the continuous improvement of existing processes to enhance efficiency and reduce costs.
- Ensure compliance with all relevant quality, safety, and environmental regulations.
Requirements
- M.Sc. or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related discipline.
- A minimum of 6 years of hands-on experience in biopharmaceutical downstream processing.
- Proven expertise in various purification techniques such as chromatography (e.g., Protein A, ion exchange, HIC) and filtration (e.g., TFF, sterile filtration).
- Experience with process simulation and modeling tools.
- Strong understanding of GMP regulations and validation principles.
- Excellent analytical and problem-solving skills.
- Proficiency in project management and technical documentation.
- Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
- Experience with single-use technologies is a plus.
- Ability to adapt to a hybrid work model, balancing remote analysis with essential on-site duties in Port Elizabeth .
Benefits
- Our client offers a competitive salary and benefits package, including comprehensive health coverage, performance bonuses, and stock options.
- You will have opportunities for professional development, including attendance at key industry conferences and specialized training programs.
- We provide a dynamic and supportive work environment where innovation is encouraged, and contributions are recognized.
- Be part of a mission-driven organization focused on improving human health through cutting-edge biotechnology in Port Elizabeth .