Biologics Process Development Engineer

Placements24; Cape Town; On-site; ZAR 1,200,000 - 1,900,000; Full time

Benefits offered by this job

Medical aid

Pension fund

Life insurance

Professional development

On-site canteen

Job summary

Placements24 is seeking a Biologics Process Development Engineer for our Cape Town facility. You will translate laboratory-scale biologics processes to pilot and commercial manufacturing, ensuring scalable, robust production and regulatory compliance.

In this role you will lead DoE studies, optimize upstream/downstream steps, and collaborate with manufacturing and QA to drive technology transfer and continuous improvement in a fast-paced biopharma environment.

Qualifications

• Master’s or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.
• 4–6 years of biopharmaceutical process development experience.
• Experience in cell culture (upstream) and/or purification (downstream) process development.
• Hands-on experience with bioprocessing equipment (bioreactors, chromatography, filtration).
• Solid understanding of cGMP principles and regulatory requirements for biologics manufacturing.
• Experience with process scale-up and technology transfer.
• Proficiency in data analysis and statistical software.
• Excellent problem-solving and collaboration skills.

Responsibilities

• Develop and optimize upstream and downstream bioprocesses for biologics manufacturing.
• Perform process characterization and validation to ensure robustness and reproducibility.
• Troubleshoot deviations and implement CAPA.
• Scale-up processes from bench to pilot and commercial scales.
• Write technical reports, development protocols, and tech transfer documents.
• Collaborate with manufacturing, quality control, and QA to ensure regulatory compliance.
• Design experiments using DoE principles and analyze results.
• Evaluate new technologies to improve process efficiency and product quality.
• Contribute to equipment and facility qualification work.

Skills

Bioprocess development

Cell culture upstream

Purification downstream

DoE / experimental design

cGMP knowledge

Data analysis (statistics)

Cross-functional collaboration

Education

Master or PhD in Chemical/Biochemical Engineering or Biotechnology

Tools

Bioreactors

Chromatography systems

Filtration units

Job description

About the Role

Our client, a renowned pharmaceutical company, is looking for a dedicated Biologics Process Development Engineer to join their state-of-the-art facility in Cape Town, Western Cape, ZA . This role is pivotal in scaling up and optimizing manufacturing processes for innovative biologic drugs. You will be instrumental in translating laboratory-scale processes to pilot and commercial manufacturing, ensuring robust, reproducible, and efficient production. This position offers a unique opportunity to work with cutting-edge biotechnology and contribute to the supply of life-saving therapies. The vibrant city of Cape Town provides an inspiring backdrop for this technically challenging and rewarding career. We are committed to fostering an environment of scientific rigor and collaboration.

Key Responsibilities

• Develop and optimize upstream and downstream bioprocesses for the manufacture of therapeutic proteins and antibodies.
• Perform process characterization and validation studies to ensure process robustness and reproducibility.
• Troubleshoot process deviations and implement corrective and preventative actions (CAPA).
• Scale-up processes from benchtop to pilot and commercial manufacturing scales.
• Author technical reports, development protocols, and technology transfer documents.
• Collaborate with manufacturing, quality control, and quality assurance departments to ensure regulatory compliance.
• Design and execute experiments using statistical design of experiments (DoE) principles.
• Evaluate and implement new technologies to improve process efficiency and product quality.
• Participate in the design and qualification of new manufacturing equipment and facilities.

Requirements

• Master's or Ph.D. degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 4-6 years of experience in biopharmaceutical process development, with a strong focus on biologics.
• Proven experience in cell culture (upstream) and/or purification (downstream) process development.
• Hands-on experience with various bioprocessing equipment (e.g., bioreactors, chromatography systems, filtration units).
• Solid understanding of cGMP principles and regulatory requirements for biologics manufacturing.
• Experience with process scale-up and technology transfer.
• Proficiency in data analysis and interpretation, including statistical software.
• Excellent problem-solving skills and ability to work effectively in a fast-paced environment.
• Strong communication and interpersonal skills for effective collaboration with cross-functional teams.
• Experience with single-use technologies is a plus.

Benefits

Our client provides a competitive remuneration package, including a substantial annual salary and performance-based bonuses. Comprehensive medical aid, a generous pension fund, and life insurance are standard. We support continuous professional development through training programs, conference attendance, and opportunities for further education. This role offers excellent work-life balance with generous annual leave and an on-site canteen. You will have access to advanced laboratory facilities and the chance to work on groundbreaking therapies. As this role is based in Cape Town , you will enjoy the lifestyle benefits of living in a world-class city. Our client is committed to employee well-being and professional growth, offering a clear career progression path within the organization. Join a team that is passionate about making a difference.