uniQure

Associate Director, Process Development - Lexington, MA

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Active since 09-10-2018 Job category Science, research & development
Location Lexington, MA Level Mid-Senior level
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization

The Process Development Department is a major contributor to the quality of our AAV-based products and processes. The Associate Director, Process Development in Lexington is responsible for the late stage development and characterization of manufacturing processes according to the regulations and business needs. Furthermore, the late stage PD department receives transfers of early process development located in Amsterdam and has a function in process implementation and GMP support. The department head has overall responsibility for the quality of the output of the department as well as departmental management.

The Process Development department is part of uniQure’s Operations organization. The Associated Director, Process Development is located in Lexington, MA and reports to the VP of Global Pharmaceutical Development.

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

Company related

  • Translate company strategy and objectives into departmental objectives and associated activities.
  • Proactively advise management on developments within own expertise field, represent own expertise field within/outside company.

Operations related

  • Setup and maintain a robust communication to all relevant functions that have an impact on or are impacted by the Process Development department.
  • Setup and maintain a robust communication with the Amsterdam (NL) facility, particularly with its Process Development department.

Department related

  • Management of department and responsible for the development of staff, performance appraisals and recruitment of new hires.
  • Transfer and implementation of developed USP/DSP processes from uniQure’s facility in Amsterdam to uniQure’s facility in Lexington (receiving end)
  • Further develop and support validation and implementation of robust and controllable manufacturing processes to manufacture AAV-based products.
  • Ensure and maintain a proper quality and compliance level, i.e. in line with GLP and GMP regulations and internal quality standards.
  • Responsible for applicable process characterization and process validation studies.
  • Transfer of developed USP/DSP processes to manufacturing as necessary.
  • Ensure first line support to the manufacturing operations.
  • Ensure all project tasks and responsibilities within the department are identified, approved, planned and performed in a timely manner and within budget.
  • Contribute to developing PD related budget.
  • Ensure and maintain a proper scientific rigor within the department, attend and present at international conferences and build and maintain a network consisting of internationally recognized experts.
  • Develop supporting documentation (study protocols/reports; PDDs; BPRs) for submissions and inspection to justify the process and controlling parameters.
  • Responsible for authoring/reviewing relevant IND/IMPD/BLA sections relating to process development discipline.
  • Actively participate and/or provide delegation to relevant CMC working groups in relation to process development discipline.

Qualifications:

  • Minimum requirement of a MS degree in engineering or life sciences; PhD preferred
  • Academic background (Biochemical Engineering, Chemical Engineering, Life Sciences or similar)
  • At least 7-10 years’ experience in process development, in the area of biologics, preferably gene therapy, AAV or vaccines; evidence of hands-on experience preferred
  • Experience with BEVS system is a plus
  • Experience in scale up of processes to commercial scale, and associated process validation studies
  • Experience in scale down of processes for further process characterization
  • Experience with Tech Transfer to other departments or organizations
  • At least 5 years of relevant work experience in a comparable position (similar type of work, similar group dynamics) in an industrial organization
  • Experience with policies, processes and procedures of EMA, FDA-regulations and ICH and with quality assurance and quality control systems
  • Proven experience in guidance/management of a functional group of high level professionals (several scientists, technicians)
  • Languages: fluent in English
  • Experience in a multi-cultural international organization

Core competencies:

  • Demonstrated leadership ability in order to drive results that are needed to achieve the operational company objectives.
  • High level of ownership, energy, hands on mentality and personal drive.
  • Management skills (deployment of strategy to departmental/personal objectives, management reporting).
  • People management skills, team player and attitude to motivate teams.
  • Demonstrated communication capabilities
More information
This listing is a full-time job

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

Contact information

Name Jennifer Wagner

Location

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