Posted in: Trenton Science & Engineering Jobs
The Director of Drug Product Manufacturing will be responsible for manufacturing and other CMC- related aspects of one or more of Onconova’s drug development, clinical, or commercial programs. Primary responsibilities will involve aseptic product manufacturing with some involvement in oral product manufacturing a plus. The position should provide aseptic manufacturing expertise, including oversight and guidance for contract manufacturers, and contract laboratories. The position will include on-site supervision of cGMP manufacture at off-site, contractor locations, preparation/review of manufacturing batch records, specifications, stability studies, qualification and validation of facilities, equipment, and processes, review of executed batch records and associated documentation as part of the release of drug product to meet clinical trial and commercial needs, and other activities as required. The person will perform administrative functions to ensure responsible financial management by contract manufacturers, including implementations of process and yield improvements. This person will ensure activities at contract manufacturers and laboratories are in compliance with the appropriate Supply and Quality Agreements, and will work closely with the Regulatory/QA function to assure that product manufacturing and testing requirements are in compliance with cGMPs, and US and international regulatory compliance expectations. A minimum of 15% international travel required.