Kevin Hutter Email & Phone Number

Newtown Square, Pa, Us

Collegeville, Pennsylvania, United States

Small Scale Drug Product Process Development (SSPD) SME. Implemented small scale drug product (DP) filling and stoppering line capability within DP development workflow. Led vial and syringe filling studies for various clinical stage assets such as process parameter development for clinical fills, derisk potential manufacturing issues, new primary pack component selection/feasibility, and fill for large stability studiesLed biopharm DP process modeling workstream, delivering predictive models to assist in experimentation and scale up for DP unit operations including mixing, shear, and fillingContributed to Autoinjector delivery time modeling, focused on mechanistic understanding and empirical assessment of PFS siliconization. Characterized siliconization of various types of syringes using optical and refractory methods

Collegeville, Pennsylvania, United States

Served as a Drug Product Lead for a pre-clinical asset for HIV therapy. Led asset transitioning from discovery to FTIH clinical studies including HTF developmentServed as a Drug Product lead for a pre-clinical asset for MS therapy. Led asset transitioning from discovery to FTIH clinical studies including platform formulation verification, container closure selection, tech transfer to clinical manufacturing site, and clinical in-use compatibility studiesAuthored and reviewed internal reports and sections of regulatory documents (IND/IMPD sections S.6, S.7, P.1, P.2, P.7, and P.8) for early and late stage clinical projects

Upper Merion, Pa

Designed and executed studies to support clinical and commercial projects such as formulation development, forced degradation, compatibility, functional testing, and stabilityIssued technical reports summarizing the results of formulation development, forced degradation, compatibility, functional testing, and stability testing studies

Gibbstown, Nj

• Developed formulations and processing for viscous color solutions for use in nail lacquer coatings.• Project Management and Team Leader experience • Brought products from small scale R&D through production scale up. • Used various techniques to such as DOE to optimize products. • Presented results and progress to upper management and ownership for technical and financial viability.

Gaithersburg, Md

• Tested samples for a study of protein stability in silicone oil lubricated prefilled syringes. • Used visual, MFI, HIAC, Instron, and SEC to quantify results. • Results presented at MedImmune summer intern poster session 2013

Bachelor Of Chemical Engineering, Chemical Engineering

Activities and Societies: Tau Beta Pi Phi Mu Alpha Marching Band Jazz Ensemble

Master Of Engineering - Meng, Chemical Engineering