Process Development Associate II

KBI Biopharma; Boulder (CO); On-site; USD 55,000 - 75,000; Full time

Job summary

KBI Biopharma in Colorado is seeking a Process Development Associate II to drive robustness and consistency in laboratory execution within the Process Development team. This role leads on projects, trains staff on system operations, and ensures documentation meets quality standards.

You will work under supervision while applying science to improve unit operations such as fermentation, chromatography, and filtration, with emphasis on safety and compliance in a fast-paced biotech environment.

Qualifications

• Requires AS/BS/MS with related lab experience.
• Knowledge of lab document control and quality standards.
• Experience with fermentation, chromatography, filtration is preferred.
• Ability to train junior staff on lab systems.

Responsibilities

• Supports and executes laboratory studies with limited oversight.
• Author operational documents for unit operations and systems.
• Apply scientific methods to solve problems of moderate scope.
• Serve as operational lead on specific projects.
• Train staff on systems and ensure compliance.

Skills

Laboratory operations

Technical writing

Troubleshooting

Training and mentoring

Regulatory/compliance awareness

Education

AS in Biotechnology or related field

BS/MS in microbiology/biochemistry/chemistry/engineering or related

Tools

Stainless fermentors

Pilot-scale fermentors

Single-use fermentors

Chromatography skid

Bench/ pilot filtration systems

Job description

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.

Position Responsibilities

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

Minimum Requirements

A.S. specifically in Biotechnology or associated field, or B.S./M.S. degree in microbiology, biochemistry, chemistry, engineering, or related area (with equivalenttraining). A.S./B.S. degree and a minimum of 2+ years of related experience; M.S. and 0+ years of related experience.

Salary

Salary: $55,000-$75,000 The Process Development Associate II is a salaried, exempt position, with the expectation to work off-hours shift work when necessary, depending on laboratory activities and organizational need. The position offers salary differential incentive for working off-hours on a consistent basis.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. 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.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.