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Engineer II, Downstream Process Development Lexington United States,  

Posted on : 07 May 2017

Project Description

Place in the Organization: uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working lives by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need. The Process Development department is part of uniQure’s Operations organization. This department is responsible for the development of GMP manufacturing processes of our AAV-based gene therapy products. As a key member of the process development department, the Engineer II is responsible for the late stage process development, process characterization, technology transfer and GMP manufacturing technical support. This position is located in Lexington, MA and reports to the Sr. Manager Downstream Process Development. Key result areas (major duties, accountabilities and responsibilities): Plan and design (with guidance) and execute (independently) late-stage purification development experimental studies Perform, optimize and maintain linear scale down models, record and maintain laboratory notebook, analyze and present small scale data and author development reports Support scale-up chromatography processes (including affinity, IEX, HIC, etc.) and filtration processes (including UF/DF, depth filtration, and sterile filtration, etc) Assist manufacturing operators with downstream unit operations and provide “on-floor” manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP production Assist technology transfer to GMP manufacturing between uniQure facilities by generating process description documents, technology transfer reports, reviewing master batch records and providing on-floor support for transfer operations Qualifications & Skills: B.S. or M.S. degree in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 2 years of process development experience Experience in process development, preferable in the area of downstream purification including column chromatography, AKTA chromatography systems, Unicorn software, TFF, and depth filtration Experience with technology transfer and GMP manufacturing technical support is preferred Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems Core competencies: Strong communication skills, including writing and oral presentations Strong technical leadership and strong analytical skills Ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands Pro-active attitude, flexible, professional, independent and a team player


Lexington, MA, USA

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