uniQure

Analytical Development Specialist - Lexington

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Job

Active since 20-09-2018 Job category Quality / Health / Environment ...
Location Lexington Level -
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 Analytical Development (AD) is a part of Process Development (PD) department in uniQure’s Operations organization. Process Development group works on the development of GMP manufacturing processes and analytical methods of our AAV-based gene therapy products. AD group 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 Analytical Development Specialist position is located in Lexington, MA and reports to the Testing group lead within Analytical Development. This individual will provide analytical testing support and method qualification, interact extensively with other groups within uniQure, including Upstream and Downstream teams in Process Development.

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

  • Perform 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 HPLC, ELISA, Cell-based assay, SDS-PAGE, Western Blotting, and other requested assays
  • Involve in lab management and maintenance
  • Participate in method qualification and transfer, support assay validation and assay trouble shooting
  • Provide analytical support in cross-functional project teams, investigation teams and the CMC teams

Qualifications & Skills:

  • B.S or M.S degree in Analytical Chemistry, Biochemistry, Biophysics or related disciplines with a minimum of 2 years of relevant post-graduation experience (including experience in biotech industry) is required
  • Hands-on experience in analytical development of biologics is required, experience in viral vaccines or gene therapy is a plus
  • Experience with method qualification, transfer to GMP labs, assay trouble shooting and process/product investigations are a plus

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 Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Analytical Development

Contact information

Name Jennifer Wagner

Location

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