Process Development Associate II

KBI Biopharma•Boulder, CO

1d•$55,000 - $75,000•Onsite

About The Position

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 II supports and executes laboratory studies within the KBI Process Development organization at KBI under general supervision, with limited oversight. The Process Development Associate II is able to execute lab studies, with documentation and reporting that is consistent with Process Development compliance and Quality standards. The Process Development Associate II works under the general supervision of laboratory management with work reviewed for soundness and accuracy. The Process Development Associate II is proficient at authoring operational documents of varying complexity for unit operations and systems within the laboratory and possesses moderate technical writing and communication skills. The Process Development Associate II will have the ability to apply scientific approaches to solve technical problems of small scope/moderate complexity. The Process Development Associate II serves as an operational lead for specific projects on a consistent basis. The Process Development Associate II will have a will have a theoretical understanding of at 1-2 methods/unit operations (e.g., harvest clarification, fermentation, chromatography, depth filtration, UFDF) in the process development function as well as understanding scientific principles in order to execute these unit operations. The Process development Associate II will be a SME/system owner on 1-2 systems within the laboratory (e.g., stainless fermentors, pilot-scale single-use fermentors, pilot-scale chromatography skid, bench-scale chromatography or fermentation systems) and be able to train junior staff on these systems proficiently. Practical understanding of laboratory equipment and operations and an ability to troubleshoot processes/equipment with moderate supervision is required. Mechanical and hands on competencies are required. The Process Development Associate II participates in process development meetings and technical investigations, presenting data and information when needed. The Process Development Associate II will identify, evaluate, develop, and implement new technologies leading to process improvements and efficiency of operations. The Process Development Associate II will identify and implement continuous operation improvement ideas as a major part of this role. The Process Development Associate II will be responsible for maintaining training compliance, according to site expectations.

Requirements

A.S. specifically in Biotechnology or associated field, or B.S./M.S. degree in microbiology, biochemistry, chemistry, engineering, or related area (with equivalent training).
A.S./B.S. degree and a minimum of 2+ years of related experience; M.S. and 0+ years of related experience.
Practical understanding of laboratory equipment and operations.
Mechanical and hands on competencies are required.

Nice To Haves

Experience in various stirred tank fermentations (single-use and stainless), chromatography, precipitation, and filtration methods are highly preferred.

Responsibilities

Supports and executes laboratory studies within the KBI Process Development organization at KBI under general supervision, with limited oversight.
Executes lab studies, with documentation and reporting that is consistent with Process Development compliance and Quality standards.
Works under the general supervision of laboratory management with work reviewed for soundness and accuracy.
Is proficient at authoring operational documents of varying complexity for unit operations and systems within the laboratory.
Possesses moderate technical writing and communication skills.
Applies scientific approaches to solve technical problems of small scope/moderate complexity.
Serves as an operational lead for specific projects on a consistent basis.
Has a theoretical understanding of at 1-2 methods/unit operations (e.g., harvest clarification, fermentation, chromatography, depth filtration, UFDF) in the process development function.
Understands scientific principles in order to execute these unit operations.
Serves as a SME/system owner on 1-2 systems within the laboratory (e.g., stainless fermentors, pilot-scale single-use fermentors, pilot-scale chromatography skid, bench-scale chromatography or fermentation systems).
Trains junior staff on these systems proficiently.
Troubleshoots processes/equipment with moderate supervision.
Participates in process development meetings and technical investigations, presenting data and information when needed.
Identifies, evaluates, develops, and implements new technologies leading to process improvements and efficiency of operations.
Identifies and implements continuous operation improvement ideas.
Maintains training compliance, according to site expectations.