About the Role
Our client, a dynamic biotechnology firm, is actively seeking a highly experienced Senior Process Development Scientist to join their innovative team based in **Rustenburg, North West**. This critical role will focus on the design, optimization, and scale-up of biopharmaceutical manufacturing processes. You will be instrumental in translating laboratory-scale discoveries into robust, commercially viable production methods, ensuring product quality and efficiency. The ideal candidate possesses a deep understanding of upstream or downstream bioprocessing, coupled with a strong scientific foundation and hands‑on experience in process development. This is a unique opportunity to contribute to the development of life‑saving therapies within a rapidly growing sector. We are committed to fostering a collaborative research environment that encourages innovation and scientific excellence. The position comes with an attractive salary and a comprehensive benefits package, reflecting the significance of this role in our **Rustenburg, North West** operations.
Key Responsibilities
- Design and execute experiments to optimize biopharmaceutical manufacturing processes, including cell culture, fermentation, purification, and formulation.
- Develop and validate scalable processes that meet regulatory requirements (e.g., GMP) and product specifications.
- Perform risk assessments and implement control strategies to ensure process robustness and product consistency.
- Utilize Design of Experiments (DoE) principles to efficiently optimize process parameters.
- Troubleshoot and resolve complex process-related issues, ensuring minimal disruption to production timelines.
- Analyze process data, interpret results, and generate detailed technical reports and development protocols.
- Lead technology transfer activities for new processes from development to manufacturing scale.
- Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs.
- Mentor and provide technical guidance to junior scientists and engineers within the process development group.
- Stay current with industry trends, new technologies, and regulatory guidelines relevant to biopharmaceutical process development.
Requirements
- A Master's or Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related life science field.
- A minimum of 5 years of progressive experience in biopharmaceutical process development and scale-up.
- Demonstrated expertise in upstream (e.g., bioreactor operation, cell culture optimization) or downstream (e.g., chromatography, filtration, viral inactivation) processing.
- Proven experience with Design of Experiments (DoE) and statistical analysis tools.
- Familiarity with GMP regulations and guidelines relevant to biopharmaceutical manufacturing.
- Strong analytical and problem-solving skills, with the ability to work effectively under pressure.
- Excellent written and verbal communication skills, including technical report writing and presentation abilities.
- Experience working in a **Rustenburg, North West**-based research or manufacturing environment is beneficial.
Benefits
- Our client offers a competitive base salary complemented by annual performance bonuses.
- A robust retirement annuity scheme and comprehensive private medical aid coverage are provided.
- We invest in our employees' growth through dedicated training budgets for conferences, workshops, and professional certifications.
- Employees receive an attractive annual leave allowance, generous sick leave provisions, and observance of all national public holidays.
- Support for work-life balance is a priority, with flexible working arrangements where applicable.
- The **Rustenburg, North West** site features modern laboratory facilities and a collaborative team atmosphere.