Senior Engineer

Job Title: Senior Engineer

Work Location: Boulder County, Colorado

Summary:

Seeking an experienced engineer to join a team focused on downstream process development for biologics and bioproducts. This role involves hands-on laboratory work, process optimization, and the translation of bench-scale findings to pilot and commercial manufacturing. The position requires strong experimental, analytical, and cross-functional collaboration skills, with opportunities to support technology transfer and process scale-up.

Responsibilities:

• Develop and optimize downstream processes at the bench scale for biologics and bioproducts.
• Design, execute, and analyze experiments involving purification operations such as chromatography, filtration, and precipitation.
• Establish scalable operating ranges, identify critical process parameters, and enhance yield, purity, and throughput for purification steps.
• Support technology transfer to manufacturing sites by preparing documentation, protocols, and transferring process knowledge.
• Translate laboratory findings into continuous models to predict process flow rates, unit sizes, and overall costs.
• Prepare and review technical reports, batch records, protocols, and assessments to support project milestones.
• Ensure data integrity, traceability, and reproducibility in all experiments and documentation, aligning with quality and regulatory standards.
• Collaborate with cross-functional teams to ensure seamless process performance and timely project execution.

Qualifications:

• B.S. or higher in Chemical Engineering, Biochemical Engineering, Bioengineering, or a related field.
• 5+ years (B.S.) or 0–2 years (M.S./Ph.D.) of relevant experience in small molecule purifications, bioprocessing, or process development (industry or strong graduate/lab experience).
• Hands-on experience with one or more of the following: chromatography (resin screening, column packing, scale-down models), TFF/UFDF systems (membrane selection, flux optimization, shear sensitivity, fouling mitigation), crystallization (solubility studies, process design, solid-liquid-separation methods), or continuous process modeling (using advanced software or manually).
• Proficiency in experimental design and data analysis using tools such as Python, R, or Excel.
• Strong technical writing skills.
• Experience with scale-up, technology transfer, or supporting manufacturing campaigns is preferred.
• Knowledge of process characterization, risk assessment (FMEA), and Quality by Design (QbD) concepts is advantageous.
• Ability to travel as needed, with experience in cost-of-goods analysis, capacity/throughput assessments, and adherence to lab safety and troubleshooting best practices.

Published Category: Analytical & Process Development