Scientist II
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About The Position
KBI Biopharma is seeking a Scientist II who is passionate about performing analytical testing in collaboration with both internal and external pharmaceutical clients. This role is integral to the KBI Boulder Analytical Development team within the Analytical and Formulation Services (AFS) department, focusing on the development and support of testing for Good Manufacturing Practice (GMP) activities. The successful candidate will be responsible for developing, troubleshooting, and executing bio-analytical techniques such as HPLC/UPLC, CE-SDS, icIEF, SDS-PAGE, and various plate-based assays including ELISA. The position requires performing testing and investigations in a GMP laboratory environment, authoring and reviewing high-quality GMP data, client protocols, and reports, as well as method qualification and validation protocols that meet publication and regulatory standards. In this role, the Scientist II will provide technical support for clinical manufacturing and product testing, while also contributing to ongoing efforts aimed at improving efficiency and processes within the laboratory. Adherence to safety requirements and procedures is paramount. The ideal candidate will demonstrate a commitment to continuous improvement, the generation of high-quality data and documentation, and a proactive approach to addressing scientific opportunities. The position demands a strong understanding of microbial protein therapeutic process development and the analytical tools necessary for this work, alongside effective communication and collaboration with team members to support process development and problem-solving. The Scientist II will also be responsible for designing and performing the development of analytical test methods, ensuring accurate documentation of results through electronic notebooks and technical documents. This role includes providing support for the review and approval of analytical test methods, study protocols, and technical reports, as well as preparing technical updates for both internal and client review. The candidate will present data, timelines, and method updates to various teams to facilitate decision-making and client feedback, while also guiding and mentoring junior staff in method development and GMP testing.
