Process Development Engineer - Biologics

About the Role

Our client is seeking an experienced Process Development Engineer specializing in Biologics to join their state-of-the-art manufacturing facility in Bristol . This role is pivotal in designing, optimizing, and scaling up biopharmaceutical manufacturing processes to ensure efficient and robust production of therapeutic proteins and other biological products. You will work with cross-functional teams, including upstream and downstream processing, analytical development, and quality assurance, to translate laboratory processes into viable commercial manufacturing operations. This is a challenging and rewarding role for an engineer passionate about biopharmaceutical manufacturing.

Key Responsibilities

• Develop and optimize upstream and downstream processes for the manufacturing of biologic drug substances.
• Perform process characterization studies and risk assessments to ensure process robustness and control.
• Scale-up processes from laboratory to pilot plant and commercial manufacturing scales.
• Troubleshoot process deviations and implement corrective and preventative actions (CAPAs).
• Collaborate with analytical teams to define critical quality attributes (CQAs) and critical process parameters (CPPs).
• Author process development reports, technology transfer documents, and regulatory submission sections.

Requirements

• Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
• Minimum of 4 years of experience in process development for biologics manufacturing.
• Hands-on experience with cell culture, fermentation, purification techniques (e.g., chromatography, filtration), and aseptic processing.
• Proficiency in process modeling and simulation software is a plus.
• Strong understanding of GMP, process validation, and regulatory requirements for biologics.
• Excellent problem-solving skills and ability to work effectively in a team-oriented, fast-paced environment in Bristol .

Benefits

• Competitive salary and performance-based incentive programs.
• Comprehensive medical, dental, and vision insurance.
• Generous pension contribution and life insurance benefits.
• Relocation assistance available for candidates moving to the Bristol area.
• Opportunities for continuous learning and professional development in the rapidly evolving field of biologics.