About the Role
Our client, a rapidly expanding biopharmaceutical company, is seeking a highly skilled Senior Process Development Scientist to join their Manufacturing and Technical Operations team in Polokwane, Limpopo . This hands‑on role is integral to the development, optimization, and scale‑up of robust manufacturing processes for novel biopharmaceutical products. You will work with state‑of‑the‑art technologies, troubleshoot complex process challenges, and ensure the efficient and compliant production of biologics. This position requires a strong background in biochemical engineering, cell culture, protein purification, and process validation. Your expertise will directly contribute to bringing life‑changing therapies to patients.
Key Responsibilities
- Develop, optimize, and scale up upstream (cell culture) and/or downstream (purification) processes for biopharmaceutical products.
- Conduct experiments to define critical process parameters (CPPs) and critical quality attributes (CQAs).
- Design and execute studies for process characterization and validation.
- Troubleshoot and resolve technical issues encountered during process development and manufacturing.
- Utilize process modeling and statistical tools for data analysis and process understanding.
- Collaborate with analytical development, formulation development, and quality assurance teams.
- Author technical reports, development protocols, and regulatory submission documentation.
- Ensure all activities are conducted in compliance with GMP, safety regulations, and company policies.
- Stay updated on the latest advancements in bioprocessing technologies and industry best practices.
- Mentor junior scientists and contribute to a culture of scientific excellence.
Requirements
- Ph.D. or Master's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field.
- A minimum of 5 years of relevant experience in biopharmaceutical process development.
- Proven expertise in upstream (e.g., mammalian cell culture, bioreactors) and/or downstream (e.g., chromatography, filtration) process development.
- Strong understanding of GMP principles and regulatory requirements for biologics manufacturing.
- Experience with process scale-up from lab to pilot or manufacturing scale.
- Proficiency in data analysis software (e.g., JMP, Minitab) and experience with DOE.
- Excellent problem‑solving, analytical, and technical writing skills.
- Strong communication and interpersonal skills, with the ability to work effectively in a multidisciplinary team.
- Experience with single‑use technologies is a plus.
Benefits
- Our client offers a competitive salary, performance bonuses, excellent health, dental, and vision insurance, retirement savings plan contributions, and significant opportunities for professional development and career progression.
You will be working at a cutting‑edge facility in Polokwane, Limpopo , contributing to the development of novel biotherapeutics.