Process Development Associate II

About this role

Position Summary: The Downstream Process Development Associate II supports and executes laboratory studies within the KBI Biopharma (KBI) Downstream Process Development organization under general supervision.

Position Responsibilities: • Conducts laboratory experiments in support of downstream/drug substance process development including preparing solutions, running downstream unit operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.), sampling and executing basic analysis of process samples (concentration, pH, conductivity, etc.). • Exercises judgment within defined procedures and practices to determine appropriate action (sometimes called upon to exercise judgment outside of defined procedures). • Observes and analyzes data resulting from executed experiments; identifies and troubleshoots unexpected results with input and/or review from peers or management. • Compiles data and contributes to drafting of templated technical documents. May contribute to client presentation development and may interact with clients. • May contribute to the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities. • Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation. Reviews documentation and records as assigned. • Contributes to general lab maintenance and operation excellence initiatives in accordance with internal guidance. Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste. • Reacts to change productively and handles other essential tasks as assigned.

Minimum Requirements: • Process Development Associate II requires a B.S. degree and 2+ years experience or a M.S. degree. • Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines. Flexibility of hours to support downstream processes. Knowledge of GMPs and biotechnology-derived product regulations preferred.

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.

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