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Senior Manager/Engineer

San Diego, CA

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REQUIREMENTS: Degree in relevant engineering discipline: Ph.D. with 5 years, MS with 9 years, or BS with 12 years of relevant development or engineering experience in the pharmaceutical or biotechnology industry A broad understanding of process engineering/development of biologic and/or nucleic acid drug substance Demonstrated ability to manage technology transfer and scale up of drug substance manufacturing processes Experience managing GMP manufacturing operations for clinical or commercial drug substance Proven ability to work in a team environment to solve complex technical and equipment qualification challenges Experience working with nucleic acid products is a plus Proficiency with quality by design concepts, mathematical modeling software for design of experiments and data trending, statistical process control, and complex data analysis Knowledge of relevant cGMP and quality guidelines Ability to effectively represent the company with external partners Experience in providing scientific/technical due diligence support for business development activities Excellent oral and written communication skills Travel to contract manufacturing sites to support manufacture and technology transfer is required

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