uniQure

Scientist / Sr. Scientist Analytical Development - Lexington, MA

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Active since 15-08-2017 Job category Science, research & development
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 (PD) department is part of uniQure’s Operations organization. This department is responsible for the development of GMP manufacturing processes and analytical methods of our AAV-based gene therapy products. Analytical Development group in PD is responsible for the late stage assay development, qualification, method transfer to QC, assay validation support, assay remediation, as well as internal analytical testing support. This Scientist/Sr. Scientist position is located in Lexington, MA and reports to the Sr. Manager of Analytical Development. This individual will provide technical leadership in analytical development for cross-functional project teams and CMC teams, establish analytical assay capability and interacts extensively with other groups within uniQure, including Upstream and Downstream teams in Process Development, early stage Analytical Development, Quality Control, Manufacturing, Engineering, QA and Regulatory Affair etc.

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

  • Establish critical analytical assays, participate in building up a new analytical lab for the method development and optimization, as well as the testing supports of PD studies including qPCR, HPLC, ELISA, Cell-based assay, SDS-PAGE, Western Blotting, and other requested assays
  • Develop and transfer qualified assays to QC, and support assay validation and assay trouble shooting
  • Lead analytical projects including but not limited to formulation, stability and other related programs
  • Provide analytical support in cross-functional project teams, investigation teams and the CMC teams
  • Analyze current assay performance to identify gaps and to develop assay development and remediation plan for late stage programs of AAV-based gene therapy products and processes, per FDA/EMA regulations and ICH guidelines

Qualifications & Skills:

  • B.S, M.S or Ph.D. degree in Analytical Chemistry, Biochemistry, Biophysics or related disciplines with a minimum of 10 years of relevant post-graduation experience (including intensive experience in biotech industry) is required
  • Broad hands-on experience in analytical development of biologics is required, experience in viral vaccines or gene therapy is a plus
  • Experience with method transfer to GMP labs, assay trouble shooting and process/product investigations are required
  • Experience of assay development and validation with EMA/FDA regulations, ICH guidelines, GMP and quality systems is preferred

Core competencies:

  • Strong communication skills, including writing and oral presentations
  • Strong technical and analytical skills
  • Take initiative, being willing to work in a fast-paced environment with demonstrated capacity to handle multiple tasks and demands
  • Pro-active attitude, flexible, professional, independent and a team player
More information
This listing is a full-time job

Job category Science, research & development
Industry / Industries Pharmaceutical
Region United States
Keywords Analytical Development, Process Development

Contact information

Name Jennifer Wagner

Location

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