Process Development Associate - Downstream

Position Summary

This position resides in the Process Operations team in the Process Development department and drives robustness and consistency in the laboratory through execution and innovation of laboratory practices. They drive efficiencies in Process Development while maintaining ownership of the laboratory and systems. They will have the responsibility of being operations leads on projects with increasing ownership and collaboration within the department.

Through defined roles and responsibilities, the process operations team will be subject matter experts (SMEs) on both the execution of processes as well as the systems in the laboratory. The Process Development Associate supports and executes laboratory studies within the KBI Process Development organization at KBI under general supervision. The Process Development Associate is able to execute lab work, with documentation and reporting that is consistent with Process Development compliance and Quality standards.

The Process Development Associate is able to author basic operational documents for routine unit operations within the laboratory organization. The Process Development Associate is capable of executing lab studies from written documents and applies standard scientific approaches to solving technical problems. The Process Development Associate may serve as the point of contact for a specific laboratory project. The Process Development Associate works under the general supervision of laboratory management with work reviewed for soundness and accuracy.

The Process Development Associate will have a basic understanding of Process Development methods/unit operations as well as scientific principles in order to execute lab studies. The Process Development Associate will have the ability to execute laboratory experiments from written/verbal instruction. Basic technical writing and communication skills are desired. Basic understanding of laboratory equipment and equipment maintenance are required. The Process Development Associate participates in process development meetings and technical investigations if needed.

Experience in various stirred tank fermentations (single-use and stainless), chromatography, precipitation, and filtration methods are highly preferred. The Process Development Associate will assist in the evaluation, development and implementation of new technologies leading to process improvements and efficiency of operations. The Process Development Associate will identify and implement continuous operation improvement ideas as a major part of this role. The Process Development Associate will be responsible for maintaining training compliance, according to site expectations.

• Conduct laboratory experiments in support of process development, including preparing solutions, running unit operations (fermentation, homogenization, clarification, filtration, chromatography, etc.), and executing basic analysis of process samples (absorbance, solids content, plating, pH, conductivity, metabolites, etc.).
• Document procedures, observations, and results in electronic laboratory notebooks.
• Exercise judgment within defined procedures and practices to determine appropriate action and, when necessary, exercise judgment outside of defined procedures.
• Make detailed observations about experimental deviations from expectations and carry out elementary analysis of the data to determine data that should be rejected due to exceptional laboratory conditions.
• Understand experiments and conduct troubleshooting analysis.
• Maintain and update knowledge of instrumentation and maintenance, scheduling periodic maintenance for laboratory equipment.
• Ensure proper labeling, handling, and storage of all chemicals used in the area; ensure proper labeling and disposition of hazardous waste in satellite areas; adhere to all safety requirements and attend all required safety and health training.
• React to change productively and handle other essential tasks as assigned.

• B.S. degree in microbiology, biochemistry, chemistry, engineering, or related area (with equivalent training).
• A.S./B.S. degree and 0+ years of related experience.

Process Development Associate I: $55,000-$75,900

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its workforce. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.