Simone K.

Simone K. has a diverse work experience spanning over several years in the pharmaceutical and biotech industries. Simone started their career as an R&D Technician at MilliporeSigma in 1996, where they presented progress reports and maintained mammalian cell cultures. Simone then worked as a Validation Project Leader at MilliporeSigma from 1998 to 2002, where they coordinated and performed bacterial retention studies for drug manufacturing under FDA regulations.

In 2002, Simone became a Supervisor at Charles River Laboratories, managing laboratory activities and ensuring quality control within the formulation and sample processing. Simone then joined Formatech Inc in 2005 as a QC Microbiologist Specialist, providing monitoring and mentoring to associates and assisting in solving laboratory issues.

Simone's career progressed as they became an Associate Project Manager at MedImmune Inc in 2006, leading global project teams in the Translational Science department. Simone provided project management support, facilitated team meetings, and addressed business issues. Simone continued their project management roles at Novartis from 2013 to 2018, overseeing companion diagnostic development and supporting drug trials.

In 2018, Simone joined MilliporeSigma as a Senior Project Manager, where they led customer-facing projects for drug product development and manufacturing services. Simone planned and executed project plans, from tech transfer to GMP drug manufacturing and fill. At axogen, from 2019 to 2020, Simone served as a BLA Program Manager, leading a cross-functional team in meeting quality and regulatory requirements for the Avance Biologics Licensing Application.

Simone's experience in program management continued at Lumos Diagnostics from 2021 to 2022, where they defined project scope and managed the execution of New Product Development projects. Simone also supported commercialization activities and regulatory submissions, attending Pre-submission meetings at FDA.

Currently, Simone is a Senior Drug Development Program Manager at CMK Select, responsible for managing oncology drug development collaborations with partnering companies. Simone creates structure, cleans up SharePoint sites, and serves as the owner of the collaborations workstream.

Throughout their career, Simone has demonstrated strong project management skills, regulatory knowledge, and the ability to lead cross-functional teams in achieving goals and meeting quality standards.

Simone K. started their education by obtaining a Bachelor of Science degree in Biochemistry from Northeastern University in 1997. Simone then pursued a Graduate Certificate in Foundations of Business from the University of Massachusetts in an unspecified year, before proceeding to complete their Master of Business Administration (MBA) degree in Business from Rivier University from 1999 to 2002.