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Job #02925

About our client Our client is a rapidly growing CRO that focuses on conducting research and providing resources for the development of oncology and infectious disease therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director, GMP Bio-Manufacturing Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct GMP manufacturing activities, including commercial contract manufacturing activities, government sponsored GMP manufacturing activities, process development and scale-up efforts 2) Lead GMP manufacturing at a FDA-licensed facility manufacturing raw materials (biologics) for diagnostic test kits 3) Prepare technical proposals in response to manufacturing opportunities (commercial and government) 4) Assist with preparing cost proposals 5) Interact with clients on technical, budget and timeline matters 6) Provide technical input on external contract manufacturing activities 7) Perform site visits (external manufacturing facilities) 8) Review and approve batch records, validation protocols and reports 9) Prepare CMC documentation for INDs 10) Participate in project team meetings as a CMC representative Requirements 1) Bachelor's degree in a scientific field (Master’s and/or Ph. D. preferred) 2) 10 – 20 years of industrial cGMP biologics experience (protein therapeutics and/or vaccines) 3) Experience in CMC 4) Background in science and the ability to apply that knowledge to complex vaccine/drug development issues within the framework of applicable regulatory requirements 5) Hands-on experience within a biopharma manufacturing facility (production of protein using mammalian and/or bacterial cell culture and downstream purification) 6) Experience with viral vectors and/or DNA platforms a plus 7) Understanding of biopharma manufacturing process equipment (fermenters, bioreactors, wave bags, purifications, chromatography, filtration, WFI, utilities and HVAC) 8) Familiarity with manufacturing of biologics 9) Excellent communication skills (written and verbal) 10) Highly productive team member with ability to make insightful contributions and influence decision-making