uniQure

Principal Scientist/Team Lead Process Development - Amsterdam

All jobs Print Apply
English

Job

Active since 04-06-2018 Job category Quality / Health / Environment ...
Location Amsterdam Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization:

uniQure is dedicated to bring innovative therapies for unmet medical needs to patients. In doing so each function at uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life 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 at uniQure Amsterdam is responsible for process development towards Phase I/II clinical testing. In addition, the department supports the Lexington uniQure PD in process development for Phase Ill and MAA, with scaling-up, process characterization and process validation as main deliverables. The both PD departments support the various stages of process development from research to GMP manufacturing.

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

Company related

  • Translate departmental objectives into personal objectives and associated activities for the scientists
  • Proactively inform/advise the development team and the CMC team ondevelopments within own expertise field
  • Proactively interacts with other functions of uniQure to leverage knowledge and to improve the current process platform
  • Represent own expertise field within and outside the company

Operations related

  • Maintain a robust communication to all relevant functions that have an impact and are impacted by the PD department
  • Maintain a robust communication with the Lexington (US) facility, especiallywith its Manufacturing and Process Development departments

Department related

  • Develop and support implementation of a robust and reproducible manufacturing processes to manufacture rAAV-based products
  • Management of a team consisting of scientists/technicians
  • Assume a leading role in setting up development, characterization and process validation studies, in identifying tasks, planning, monitoring of progress, and in protocol and report generation.
  • Contributes to CMC team(s)
  • Represent own expertise field within/outside the company, attend and present at international conferences.
  • Ensure ability to support all regulatory documentation needed for submissions, from the process development perspective
  • Ensure and maintain a proper scientific and quality level of the output generated by the PD team.

Key Performance Indicators

  • Quality (e.g. traceable & peer reviewed docs), efficiency, scientific soundness, accuracy and reliability of the work delivered by PD team
  • Appropriate staffing: up to date assessment of individual performance, team performance, making adjustments where needed.
Qualifications & Skills:
  • Academic background (Bioprocess Engineering, Life Sciences or similar)
  • At least 5 years of relevant work experience in a comparable position (similar type of work, similar group dynamics) in an industrial (biopharmaceutical) organization
  • Experience and expertise in process development, in the area of biologics, preferably gene therapy, rAAV or vaccines
  • Proven experience in guidance/management of a functional group of high level professionals (scientists, technicians)
  • Working knowledge of regulatory framework related to process development for biologics
  • Affinity with GMP manufacturing
  • Fluency in English

Core competencies:

  • High level of ownership, energy, hands-on mentality and personal drive
  • People management skills, team player and attitude to motivate teams
  • Demonstrated communication capabilities (effectively describing and conveying complex issues through reporting and presentations)
  • Flexibility, to act in a fast changing and demanding environment
  • Strong analytical skills


More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region Netherlands
Keywords Process Development

Contact information

Name Marsha Lemmers

Location

Apply