Senior Process Development Engineer - Biologics Manufacturing

Placements24; Polokwane; Hybrid; ZAR 1,000,000 - 1,500,000; Full time

Benefits offered by this job

Medical aid

Retirement annuity

Performance-based bonuses

Hybrid work arrangement

Job summary

Placements24 is seeking a Senior Process Development Engineer for our client in Polokwane, Limpopo, to lead upstream and/or downstream biologics process development, optimization, and transfer to manufacturing. You will design experiments, model processes, and develop robust, scalable manufacturing workflows compliant with cGMP.

You will mentor junior engineers, collaborate across QA, operations, and analytics, and stay abreast of industry advances to ensure product quality and yield in a

Qualifications

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• A minimum of 6 years of experience in process development for biologics (e.g., monoclonal antibodies, recombinant proteins, vaccines).
• Proven expertise in upstream (cell culture) or downstream (chromatography/filtration) processing.
• Strong understanding of process scale-up principles and technology transfer.
• Experience with process modeling and statistical analysis is highly desirable.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong technical writing and presentation abilities.
• Ability to work effectively in a collaborative team environment.
• Familiarity with cGMP regulations and guidelines applicable to biologics manufacturing.
• Project management skills are a plus.

Responsibilities

• Lead the development and optimization of upstream (cell culture) and/or downstream (purification) processes for biologics manufacturing.
• Design and execute experiments to understand process parameters and their impact on product quality and yield.
• Develop robust and scalable manufacturing processes suitable for technology transfer to manufacturing sites.
• Perform process characterization studies and develop control strategies.
• Troubleshoot process deviations and implement corrective and preventative actions (CAPAs).
• Author technical reports, development protocols, and transfer documents.
• Collaborate with cross-functional teams, including manufacturing operations, quality assurance, and analytical development.
• Stay current with industry trends, new technologies, and best practices in biologics manufacturing.
• Manage external CDMOs as needed.
• Mentor junior engineers and scientists within the process development team.

Skills

Bioprocessing

Upstream processing

Downstream processing

Process scale-up

cGMP

Process modeling

Statistical analysis

Technical writing

Presentation skills

Project management

Education

Master's degree in Chemical/Biochemical Engineering

PhD in Biotechnology or related field

Job description

About the Role

Our client, a leader in biopharmaceutical manufacturing, is seeking a highly skilled Senior Process Development Engineer to join their innovative team in Polokwane, Limpopo . This crucial role involves the development, optimization, and scale-up of manufacturing processes for biologics, ensuring efficient and robust production of life-saving therapies. You will be responsible for translating laboratory-scale processes into commercial manufacturing operations, working with upstream and downstream processing technologies. This hybrid position offers the opportunity to collaborate closely with a talented team while enjoying flexibility. The ideal candidate will possess a strong engineering background, extensive experience in bioprocessing, and a passion for driving process improvements in a regulated environment. Your expertise will be vital in advancing our client's pipeline and ensuring the consistent quality of their biologic products.

Key Responsibilities

• Lead the development and optimization of upstream (cell culture) and/or downstream (purification) processes for biologics manufacturing.
• Design and execute experiments to understand process parameters and their impact on product quality and yield.
• Develop robust and scalable manufacturing processes suitable for technology transfer to manufacturing sites.
• Perform process characterization studies and develop control strategies.
• Troubleshoot process deviations and implement corrective and preventative actions (CAPAs).
• Author technical reports, development protocols, and transfer documents.
• Collaborate with cross-functional teams, including manufacturing operations, quality assurance, and analytical development.
• Stay current with industry trends, new technologies, and best practices in biologics manufacturing.
• Manage external contract development and manufacturing organizations (CDMOs) as needed.
• Mentor junior engineers and scientists within the process development team.

Requirements

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• A minimum of 6 years of experience in process development for biologics (e.g., monoclonal antibodies, recombinant proteins, vaccines).
• Proven expertise in upstream (e.g., bioreactor operation, cell culture optimization) or downstream (e.g., chromatography, filtration) processing.
• Strong understanding of process scale-up principles and technology transfer.
• Experience with process modeling and statistical analysis is highly desirable.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong technical writing and presentation abilities.
• Ability to work effectively in a collaborative team environment.
• Familiarity with cGMP regulations and guidelines applicable to biologics manufacturing.
• Project management skills are a plus.

Benefits

Our client offers a competitive salary and a comprehensive benefits package, including medical aid, a retirement annuity, and performance-based bonuses. We provide extensive opportunities for professional development, including training courses and attendance at key industry conferences. This hybrid role allows for a flexible work arrangement, combining in-office collaboration with remote work, based in our modern facility in Polokwane . We are dedicated to fostering a positive work environment that promotes innovation and a healthy work-life balance.

• medical aid
• a retirement annuity
• performance-based bonuses