Manufacturing Lead-Rockville, MD

Role is Hybrid, must be local to Rockville, MD (onsite 3-4 days a week)Oversight on products for the Cell & Gene Therapy ProgramMust have Contract experienceThis group processes 2 batches per weekThe volume is HIGH, so they need help with oversight of their facility, overseeing the processes and getting the products out the doorCAR-T Manufacturing experience requiredClean Room (ISO 7 / ISO 5 level) experienceAseptic environment experienceMust have excellent communication skillsProdigy manufacturing experienceExperience working with CMOsExperience with Large Molecule Manufacturing experienceExternal Supply / Manufacturing Oversight Lead.We are looking for someone that is able to perform manufacturing oversight of an external contract manufacturing organization producing a Phase Ib clinical CAR-T program.This person will be responsible for working with the contract manufacturing organization to drive improvements, oversee manufacturing operations, ensure collaboration and communication, and execute tasks such as manufacturing investigations, change controls, batch record revisions, continuous improvement efforts and corrective and preventative actions.Education Needed:Degree in a Science / Engineering related field required, with preferred focus or experience in pharmaceutical manufacturing.Bachelor’s in science related field / Engineering requiredMinimum 3-5 years’ experience in pharmaceutical manufacturing, with preference in cell and gene therapy manufacturing.Preferred experience with contract manufacturing organizations.