Process Development Scientist - Biologics Manufacturing

Placements24; Mbombela (Nelspruit); Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Performance bonuses

Health coverage

Remote work

Professional development

Home office setup

Job summary

Placements24 seeks a Process Development Scientist for a cutting-edge biotechnology company. This fully remote role focuses on designing, optimizing, and scaling biologic manufacturing processes with emphasis on GMP and DoE-driven experimentation.

You will work on upstream and/or downstream bioprocessing, develop analytical methods, and support technology transfer. A PhD or Master’s in a related field with 5+ years of biologics experience is required, along with strong problem-solving and

Qualifications

• PhD or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Microbiology, or related field.
• Minimum 5 years of experience in process development for biologics manufacturing.
• Hands-on with bioreactors, chromatography and analytical instrumentation.
• Proficiency in DoE software and statistical analysis; GMP awareness.

Responsibilities

• Design, optimize, and scale-up upstream and/or downstream processes for biologic substances.
• Develop experiments to evaluate process parameters on quality and yield.
• Use DoE methodologies for optimization and characterization.
• Develop and validate analytical methods for monitoring and characterization.
• Troubleshoot processes and support technology transfer and regulatory submissions.
• Prepare technical reports and presentations; stay updated on industry advances.
• Ensure GMP compliance and manage timelines for development milestones.

Skills

DoE methodologies

Statistical analysis

GMP knowledge

Bioprocessing

Cell culture

Chromatography

Independent remote work

Problem solving

Communication skills

Education

PhD or Master's in Chemical/Biochemical Engineering

Tools

JMP

Minitab

Chromatography systems

Analytical instrumentation

Job description

About the Role

Our client, a cutting-edge biotechnology company specializing in the development and manufacturing of novel biologic therapeutics, is seeking a highly skilled Process Development Scientist to join their innovative team. This is a fully remote position, allowing you to contribute to critical advancements in biologic manufacturing from your home office in Nelspruit, Mpumalanga. You will be instrumental in designing, optimizing, and scaling up manufacturing processes for biologics, ensuring product quality, yield, and cost-effectiveness. This role requires a deep understanding of upstream and/or downstream bioprocessing, cell culture, fermentation, or purification technologies. The ideal candidate will possess strong analytical skills, a creative problem-solving approach, and the ability to thrive in an independent, remote work environment. We are looking for a dedicated scientist who is passionate about advancing biopharmaceutical manufacturing and driving innovation.

Key Responsibilities

• Design, optimize, and scale-up upstream and/or downstream processes for the manufacturing of biologic drug substances.
• Develop and execute experimental plans to evaluate critical process parameters and their impact on product quality and yield.
• Utilize DoE (Design of Experiments) methodologies for process optimization and characterization.
• Develop and validate analytical methods for process monitoring and product characterization.
• Troubleshoot process issues and implement effective solutions to ensure process robustness and reproducibility.
• Collaborate with research, manufacturing, and quality assurance teams to ensure seamless technology transfer and process implementation.
• Prepare detailed technical reports, documentation, and presentations for internal review and regulatory submissions.
• Stay abreast of new technologies, scientific advancements, and industry trends in biopharmaceutical process development.
• Contribute to process risk assessments and ensure compliance with GMP regulations.
• Manage project timelines and resources effectively to meet development milestones.

Requirements

• PhD or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Microbiology, or a related field.
• Minimum of 5 years of experience in process development for biologics manufacturing (e.g., monoclonal antibodies, recombinant proteins, vaccines).
• Strong expertise in either upstream (cell culture, fermentation) or downstream (chromatography, filtration, viral inactivation) bioprocessing.
• Hands-on experience with laboratory-scale bioreactors, chromatography systems, and analytical instrumentation.
• Proficiency in DoE software (e.g., JMP, Minitab) and statistical analysis.
• Thorough understanding of GMP principles and regulatory requirements for biologics manufacturing.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong written and verbal communication skills, with the ability to present complex technical information clearly.
• Proven ability to work independently, manage multiple projects, and meet deadlines in a remote setting.
• Experience with technology transfer and process scale-up is highly desirable.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package designed to support your career and well-being, including performance bonuses and excellent health coverage.
• As a fully remote position, you will enjoy significant flexibility and work-life balance.
• This role provides an exceptional opportunity to work on the forefront of biopharmaceutical innovation and contribute to life-changing therapies.
• We invest in our employees' professional development through ongoing training, support for attending scientific conferences, and clear pathways for career advancement.
• Additional benefits include home office setup support and access to specialized scientific resources.