Director Drug Product (Biologic) 2049028Location: Greater Boston, MA (Hybrid)
Job Overview: This Biologics focused CMC leader will oversee formulation development, drug product manufacturing processes, and coordinate tech transfers with CDMOs.
Primary Job Responsibilities:
Drive strategic and technical initiatives for drug product development including optimization and scale up.Manage CDMO activities to ensure drug product manufacturing processes are developed and maintained.Design and execute Drug Product development studies (pre-formulation, formulation, and short-term stability).Develop liquid and lyophilized formulations to support clinical stage biologic therapies.Primary Job Requirements:
Advanced degree in a scientific field preferred with over 7 years of biologic drug product development experience.Expertise in developing lyophilized and liquid biologic formulations.Strong exposure to managing CDMO's and tech transfer related activities.Knowledgeable in ICH guidelines, GMPs, and regulatory standards with excellent teamwork and communication abilities.#J-18808-Ljbffr