Biologics Process Development Scientist

Placements24; Stellenbosch; Hybrid; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Hybrid work model

Competitive salary and bonus potential

Health, dental, vision benefits

Retirement plan

Paid time off

Job summary

Placements24 is seeking a Biologics Process Development Scientist to join a leadership-driven biopharma R&D team in Stellenbosch. The role focuses on developing and optimizing upstream and downstream processes for novel biologics, with an emphasis on scale-up and technology transfer to manufacturing.

You will design experiments, evaluate process parameters, and ensure product quality and consistency while adhering to cgMP standards and regulatory requirements.

Qualifications

• Ph.D. or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• 4–7 years in biopharmaceutical process development.
• Hands-on cell culture (upstream) and purification for biologics.
• Experience with process scale-up, optimization, and tech transfer.

Responsibilities

• Develop and optimize upstream and downstream processes for recombinant proteins and monoclonal antibodies.
• Design and execute experiments to evaluate process parameters and impact on yield, quality, and consistency.
• Scale-up lab processes to pilot and manufacturing scale with technology transfer.
• Characterize process intermediates and final drug substance using analytical techniques.
• Troubleshoot process issues and implement corrective actions.
• Contribute to process validation studies and regulatory submissions.
• Prepare technical reports and development summaries.
• Collaborate with analytical development, manufacturing, QA, and regulatory teams.
• Stay current with emerging bioprocess technologies and cGMP practices.

Skills

Bioprocess engineering

Cell culture

Purification techniques

Tech transfer

Analytical thinking

Problem solving

Education

Ph.D. or Master’s in Chemical/Biochemical Engineering or Biotechnology

Tools

HPLC

ELISA

SDS-PAGE

Job description

About the Role

Our client, a leader in biopharmaceutical innovation, is seeking a highly motivated and experienced Biologics Process Development Scientist to join their advanced research and development team. This role is critical for the development, optimization, and scale-up of manufacturing processes for novel biologic therapeutics. The scientist will work on cutting-edge projects, applying their expertise in bioprocess engineering to bring life-saving medicines from the lab to commercial production. This is an exciting opportunity for a driven individual to contribute to significant advancements in biotechnology. The position is located in the renowned wine region of Stellenbosch, Western Cape, offering a stimulating work environment and a high quality of life. We are at the forefront of biologics manufacturing and are looking for top talent.

Key Responsibilities

• Develop and optimize upstream and downstream processes for the production of recombinant proteins and monoclonal antibodies.
• Design and execute experiments to evaluate critical process parameters and their impact on product yield, quality, and consistency.
• Scale-up laboratory processes to pilot and manufacturing scale, ensuring seamless technology transfer.
• Characterize process intermediates and final drug substance using advanced analytical techniques.
• Troubleshoot process-related issues and implement corrective actions.
• Contribute to the design and execution of process validation studies.
• Prepare technical reports, development summaries, and regulatory submission documents.
• Collaborate with cross-functional teams including analytical development, manufacturing, quality assurance, and regulatory affairs.
• Stay current with emerging technologies and best practices in biopharmaceutical process development.
• Ensure all activities are conducted in compliance with cGMP and regulatory requirements.

Requirements

• Ph.D. or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 4-7 years of relevant industry experience in biopharmaceutical process development.
• Hands-on experience with cell culture (upstream) and purification techniques (downstream) for biologics.
• Proficiency in process scale-up, optimization, and technology transfer.
• Strong understanding of protein biochemistry, molecular biology, and bioprocess engineering principles.
• Experience with common analytical techniques for protein characterization (e.g., HPLC, ELISA, SDS-PAGE).
• Familiarity with cGMP regulations and their application in process development.
• Excellent problem-solving skills and ability to work independently and in a team environment.
• Strong written and verbal communication skills.
• Demonstrated ability to manage complex projects and meet deadlines.

Benefits

Our client offers a highly competitive salary, attractive bonus opportunities, comprehensive health, dental, and vision benefits, a generous retirement plan, and ample paid time off. We provide significant opportunities for professional growth, continuous learning, and career advancement within a leading biopharmaceutical company. The role follows a hybrid work model, promoting work-life balance.