Lead Biopharmaceutical Process Engineer

Placements24; George; On-site; ZAR 1,000,000 - 1,700,000; Full time

Benefits offered by this job

Medical and dental coverage

Performance-based bonus

Professional growth opportunities

Job summary

Placements24 is seeking a Lead Biopharmaceutical Process Engineer in George, Western Cape, to drive development, optimization, and scale-up of biologics manufacturing. You will oversee upstream cell culture and downstream purification, ensure GMP compliance, and manage technology transfer to pilot and commercial sites.

The role requires a PhD/Master’s in a related field and 10+ years' experience in biopharma process development, with strong leadership, regulatory knowledge, and cross-functional

Qualifications

• Requires Master's or PhD in Chemical/ Biochemical Engineering or Biotechnology.
• 10+ years in biopharmaceutical process development and manufacturing.
• Experience with mammalian cell culture (upstream) and chromatographic purification (downstream).
• GMP environment experience; technology transfer and validation.
• Strong knowledge of ICH, FDA, EMA guidelines.

Responsibilities

• Lead development, optimization, and scale-up of biopharmaceutical processes including cell culture and purification.
• Design and implement process validation strategies to ensure regulatory compliance.
• Troubleshoot technical issues in process development and manufacturing.
• Manage technology transfer from R&D to pilot and production sites.
• Develop and maintain batch records, SOPs, and validation protocols.

Skills

Leadership

Process development

Analytical thinking

Regulatory knowledge

Project management

Problem solving

Communication

Education

Master's or PhD in Chemical Engineering/ Biochemical Engineering/ Biotechnology

Tools

Process modeling software

Job description

About the Role

Our client, a prominent player in the biopharmaceutical manufacturing sector, is looking for an experienced Lead Biopharmaceutical Process Engineer to spearhead process development and optimization initiatives in George, Western Cape . This senior role is crucial for enhancing the efficiency, scalability, and robustness of our manufacturing processes for novel biologics. The ideal candidate will possess a deep understanding of upstream and downstream processing, as well as extensive experience in technology transfer and GMP environments. This position is integral to our mission of delivering life-saving therapies to patients worldwide. The Lead Biopharmaceutical Process Engineer will be instrumental in driving innovation, troubleshooting complex manufacturing challenges, and ensuring the highest standards of quality and compliance are met. This role requires strong leadership skills and a strategic vision for process excellence.

Key Responsibilities

• Lead the development, optimization, and scale-up of biopharmaceutical manufacturing processes, including cell culture and protein purification.
• Design and implement process validation strategies to ensure compliance with regulatory requirements (e.g., FDA, EMA).
• Troubleshoot and resolve technical issues encountered during process development and commercial manufacturing.
• Manage technology transfer activities from R&D to pilot plant and commercial manufacturing sites.
• Develop and maintain process documentation, including batch records, SOPs, and validation protocols.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure product quality and regulatory compliance.
• Evaluate and implement new process technologies and equipment to improve efficiency and reduce costs.
• Mentor and provide technical guidance to junior engineers and scientists within the process development team.
• Conduct risk assessments and implement mitigation strategies for process-related risks.
• Stay current with industry best practices and regulatory guidelines in biopharmaceutical manufacturing.

Requirements

• Master's or PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related discipline.
• A minimum of 10 years of progressive experience in biopharmaceutical process development and manufacturing.
• Proven expertise in mammalian cell culture (upstream) and chromatographic purification (downstream) processes.
• Demonstrated experience with process scale-up, technology transfer, and validation in a GMP environment.
• Strong knowledge of regulatory guidelines (ICH, FDA, EMA) pertaining to biopharmaceutical manufacturing.
• Excellent analytical, problem-solving, and critical thinking skills.
• Proficiency in process modeling and simulation software is an advantage.
• Exceptional leadership, communication, and interpersonal skills.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Experience with single-use technologies and continuous manufacturing is a plus.

Benefits

• Our client offers a competitive remuneration package, comprehensive medical and dental coverage, and an attractive performance-based bonus scheme.
• We provide ample opportunities for professional growth, training, and attending industry conferences.
• The successful candidate will join a state-of-the-art facility located in George, Western Cape , and become part of a dedicated team committed to innovation.
• We support employee well-being through various health and wellness programs.
• This role is based on-site to ensure direct oversight of critical manufacturing operations.