Bioprocess Engineer - Biotechnology

Mantell Associates are currently partnered with a unique biotech organisation who operate within a niche space, and currently building out a new manufacturing facility following significant investment.
As a Bioprocess Engineer, you will be responsible for designing, optimizing, and troubleshooting bioprocesses for the production of biological products. Your expertise will contribute to the development of efficient and scalable manufacturing processes that meet quality standards and regulatory requirements. This is a dynamic role that requires a strong background in bioprocessing, technical proficiency, and a passion for innovation.

Bioprocess Engineer - Responsibilities:

• Continuous Improvement and Innovation:
• Generate and maintain detailed process documentation, including batch records, standard operating procedures (SOPs), and process descriptions.
• Stay up-to-date with industry trends, new technologies, and scientific advancements in bioprocessing.
• Continuously evaluate and optimize bioprocesses to enhance yield, productivity, and product quality.
• Troubleshoot process-related issues and provide timely solutions to ensure smooth manufacturing operations.
• Design, develop, and optimize bioprocesses for the production of biological products, including upstream and downstream operations.
• Provide technical expertise during process validation activities, including process characterization, qualification, and validation protocols.
• Identify opportunities for process improvement, automation, and innovation to enhance efficiency, productivity, and product quality.
• Process Optimization and Troubleshooting:
• Documentation and Compliance:
• Support technology transfer activities, including the transfer of processes from R&D to manufacturing.
• Conduct process simulations, modeling, and scale-up studies to ensure efficient and cost-effective production.
• Technology Transfer and Scale-Up:
• Collaborate with the Quality Assurance team to conduct risk assessments, support investigations, and implement corrective actions.
• Identify process bottlenecks, perform root cause analysis, and implement corrective actions to improve process performance.
• Collaborate with cross-functional teams, such as Research and Development, Manufacturing, and Quality Assurance, to ensure seamless process integration
• Bioprocess Design and Development:
• Ensure compliance with cGMP regulations, safety guidelines, and relevant quality management systems.
• Collaborate with internal and external stakeholders to ensure successful scale-up and implementation of new processes.
• Initiate and lead process optimization projects to drive operational excellence and ensure competitiveness in the market.

Bioprocess Engineer - Requirements:

• Proven experience in bioprocess engineering, process development, or related roles within the biopharmaceutical industry.
• Experience with statistical analysis and design of experiments (DoE) for process optimization.
• Strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously.
• Familiarity with cGMP regulations and quality management systems in the biopharmaceutical industry.
• Excellent problem-solving skills and the ability to apply scientific principles to troubleshoot process-related issues.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Bachelor's or Master's degree in Chemical Engineering, Biotechnology, or a related field. A Ph.D. is a plus.
• Strong knowledge of bioprocessing principles, including upstream and downstream unit operations, process scale-up, and technology transfer.
• Proficiency in process simulation and modeling software, such as Aspen Plus, SuperPro Designer, or similar tools.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.