Kesete Kifle

Kesete Kifle has a diverse work experience in the pharmaceutical and biotechnology industry. Kesete started their career at Bayer as a Process Engineer, where they managed the start-up and validation of various systems. Later, at ADVENT Engineering, they served as a Site Project Manager, overseeing multiple capital projects and managing a team of engineers.

In 2005, Kesete joined Genentech as a Senior Validation Engineer. Kesete was responsible for authoring and executing validation protocols, generating change orders and CAPAs, and providing technical input and assessment. Kesete worked on drug product, drug substance facility, utilities, and equipment validation.

At BioMarin, Kesete served as a Senior Supervisor in QA Validation. Kesete validated the cleaning and sterilization of process equipment and managed in-house and contract validation engineers. Kesete also provided oversight for revalidation activities.

After BioMarin, Kesete moved to Bayer as a Senior Manager in the QUV department. Kesete managed a team of in-house and contract validation engineers and was responsible for qualifying facilities, utilities, and equipment for upstream and downstream processes. Kesete also played a key role in reviewing and approving qualification packages and presenting during audits and regulatory inspections.

In their most recent role as the Director of MSAT Corporate Validation at Intarcia Therapeutics, Inc., Kesete led a team of over 25 validation engineers. Kesete directed the validation department through effective team leadership and strategic planning, ensuring projects were completed on time, within budget, and fully resourced. Kesete provided validation oversight for all aspects of production systems and processes to ensure readiness for commercial GMP production. Additionally, they authored, reviewed, and approved various written standards and documentation, such as the site master validation plan, standard operating procedures, change control, deviations, and CAPAs.

Kesete Kifle holds a Bachelor's degree in Chemical Engineering from the University of California, Berkeley. The exact duration of their education at this institution is unknown.