About the Role Our client, a leading innovator in the biotechnology sector, is seeking a highly skilled and experienced Senior Bio-Process Engineer to join their dynamic research and development team. This pivotal role will be based in the vibrant city of Pietermaritzburg, KwaZulu-Natal . The successful candidate will play a crucial part in the design, optimization, and scaling of biopharmaceutical manufacturing processes. We are looking for a forward-thinking individual with a passion for scientific advancement and a proven track record in process development and validation. This position offers an exceptional opportunity to contribute to groundbreaking projects and to work within a collaborative and stimulating environment that fosters professional growth and encourages cutting-edge research.
Key Responsibilities
- Design, develop, and optimize bioprocessing protocols for novel therapeutic molecules, including upstream (cell culture) and downstream (purification) operations.
- Scale-up processes from laboratory bench to pilot and commercial manufacturing scales, ensuring robust and reproducible outcomes.
- Conduct rigorous process characterization and validation studies to meet regulatory requirements.
- Troubleshoot and resolve technical issues encountered during process development and manufacturing.
- Collaborate closely with cross-functional teams, including R&D, manufacturing, quality control, and regulatory affairs.
- Author comprehensive technical reports, protocols, and regulatory submission documents.
- Stay abreast of the latest advancements in bioprocessing technology and regulatory guidelines.
Requirements
- Master's or Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related scientific field.
- Minimum of 5 years of progressive experience in bioprocess development within the pharmaceutical or biotechnology industry.
- In-depth knowledge of mammalian cell culture, microbial fermentation, chromatography, and tangential flow filtration.
- Experience with process modeling and simulation software is a plus.
- Strong understanding of GMP (Good Manufacturing Practice) principles and regulatory affairs (e.g., FDA, EMA).
- Excellent analytical, problem-solving, and critical thinking skills.
- Proficiency in data analysis and statistical software (e.g., JMP, R).
- Exceptional communication and interpersonal skills, with the ability to present complex information clearly.
- Willingness to travel occasionally to support project needs.
Benefits
- Competitive annual salary package.
- Comprehensive health and wellness benefits.
- Opportunities for continuous professional development and advanced training.
- Generous paid time off and holiday schedule.
- Contribution to impactful scientific advancements in a growing industry.
- A collaborative and supportive work environment located in scenic Pietermaritzburg, KwaZulu-Natal .