Process Development Scientist - Biologics

Placements24; Mtubatuba Local Municipality; On-site; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Retirement plan

Professional development

Job summary

Placements24 is seeking a Process Development Scientist specializing in biologics for its Richards Bay facility in KwaZulu-Natal. You will develop and optimize upstream and downstream bioprocesses, scale from lab to pilot to commercial, and work with cross-functional teams to ensure product quality and regulatory readiness.

The ideal candidate holds a PhD in a related field with at least 5 years of biologics process development experience, including cell culture and protein purification.

Qualifications

• PhD in a relevant field such as biochemical/chemical engineering or biotechnology.
• At least 5 years of hands-on process development experience for biologics.
• Proficient in mammalian cell culture, fermentation, or protein purification.
• Strong understanding of scale-up principles and technologies.
• Experience with process analytical technology (PAT) is desirable.
• Proficiency in statistical analysis and Design of Experiments (DoE).

Responsibilities

• Develop and optimize upstream and downstream processes for biologic drug substances.
• Scale up processes from lab to pilot plant and commercial scales.
• Characterize process performance and product quality attributes.
• Troubleshoot process deviations and implement effective solutions.
• Conduct process hazard analyses and implement safety measures.
• Collaborate with upstream/downstream manufacturing, analytical development, and regulatory affairs.
• Prepare technical reports and development summaries for regulatory filings.
• Stay current with industry trends and best practices in bioprocessing.
• Contribute to the intellectual property portfolio through invention disclosures.

Skills

Cell culture

Protein purification

Process development

DoE

PAT

Statistical analysis

Project management

Communication

Education

PhD in Biochemical Engineering / Chemical Engineering / Biotechnology

Job description

About the Role

Our client, a globally recognized leader in the pharmaceutical industry, is seeking an innovative Process Development Scientist specializing in Biologics for their state-of-the-art facility in Richards Bay, KwaZulu-Natal . This role is critical for developing and optimizing robust manufacturing processes for complex biologic drug substances. The ideal candidate will have a strong scientific foundation in cell culture, protein purification, and downstream processing. This position offers an exceptional opportunity to contribute to the advancement of cutting-edge biopharmaceutical products in a research-intensive environment. Our client is dedicated to improving patient lives through scientific innovation and is looking for a passionate individual to join their advanced development team. The location in Richards Bay, KwaZulu-Natal provides access to a thriving industrial hub and beautiful coastal surroundings. We are committed to fostering an environment where scientific excellence and collaboration flourish.

Key Responsibilities

• Develop and optimize upstream and downstream processes for the manufacturing of biologic drug substances (e.g., monoclonal antibodies, recombinant proteins).
• Design and execute experiments to scale up processes from laboratory to pilot plant and commercial scales.
• Characterize process performance and product quality attributes using appropriate analytical techniques.
• Troubleshoot process deviations and implement effective solutions.
• Conduct process hazard analyses and implement appropriate safety measures.
• Collaborate with upstream/downstream manufacturing teams, analytical development, and regulatory affairs.
• Prepare technical reports, study protocols, and development summaries for regulatory filings.
• Stay current with industry trends, new technologies, and best practices in bioprocessing.
• Contribute to the intellectual property portfolio through invention disclosures.

Requirements

• Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field.
• Minimum of 5 years of hands-on experience in process development for biologics manufacturing.
• Proven expertise in mammalian cell culture, fermentation, or protein purification techniques.
• Strong understanding of process scale-up principles and technologies.
• Experience with process analytical technology (PAT) is desirable.
• Proficiency in statistical analysis and Design of Experiments (DoE).
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong project management and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Experience with regulatory submissions (e.g., IND, BLA) is a plus.

Benefits

Our client provides a highly competitive compensation package, inclusive of comprehensive medical, dental, and vision insurance, a generous retirement plan, and significant opportunities for professional development and training. Employees have access to cutting-edge laboratory facilities and the chance to work on groundbreaking therapies. The role offers a stimulating and challenging work environment focused on scientific discovery and innovation. Situated in Richards Bay, KwaZulu-Natal , the location offers a unique blend of industrial activity and natural beauty. We value our employees and invest in their long-term success and well-being.