uniQure

Senior Engineer II, Process Development Downstream (DSP) - Lexington, MA

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Active since 30-10-2017 Job category Pharmacy
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
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, this scientist of downstream process development 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 Downstream Purification manager. This individual will lead or contribute as a core member of various cross-functional teams, and interacts extensively with other departments within uniQure, including Analytical Development, Manufacturing, Engineering, Quality, and Regulatory Affair etc.

Key result areas (major duties, accountabilities and responsibilities):

  • Develop, optimize and scale-up chromatography processes (including affinity, IEX, HIC, etc.) and filtration processes (including UF/DF, depth filtration, and sterile filtration, etc)
  • Plan, design, execute late-stage purification development experimental studies and projects using QbD principles to define process parameter, ranges, specifications and control strategies
  • Develop, qualify and maintain linear scale down models
  • Guide development technicians and provide process training to manufacturing operators and junior staff
  • Explore and develop innovative downstream process technologies to improve uniQure’s proprietary AAV process and manufacturing platform
  • Lead or 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
  • Design process validation plan and support the execution of process validations and cleaning validations
  • Lead manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs
  • Author development reports, assist in the preparation and technical review of regulatory filing documents including CMC sections and supporting documents
  • Support plan and execution of process/product life cycle management, including continuous downstream process improvement to improve process robustness/capacity/productivity, and to increase level of safety and/or compliance

Qualifications & Skills:

  • PhD degree in Biochemistry/Protein Chemistry, Chemical Engineering or related discipline with a minimum of 2 years or a MS degree with a minimum of 5 years of relevant experience in biotechnology/pharmaceutical environment is required
  • Experience in process development, preferable in the area of viral vaccines or gene therapy
  • 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
  • Experienced project management skills
More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Biotechnology
Region United States
Keywords

Contact information

Name Jennifer Wagner

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