uniQure

Manufacturing Supervisor - Lexington, MA

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Job

Active since 19-03-2018 Job category Pharmacy
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
General:

uniQure is dedicated to bringing therapies for 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 life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Main purpose of the job:

The Manufacturing department has an important role regarding the quantity and quality of our AAV-based products. cGMP is applied to manufacture and verify the quality of our products to ensure (i) proper delivery and functionality as well as (ii) safety. Those activities support the whole scope of AAV product and process development. By strict application of cGMP guidelines, monitoring, and qualification of our manufacturing environment and systems, the manufacturing of drug substance and drug product is performed.

Manufacturing performs all required process steps and in process controls, in close collaboration with Process Development, SC, QC and QA.

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

  • Plans, oversees and supervises the performance of transferred and validated manufacturing steps performed both in house as well as outsourced to contract manufacturers (e.g. buffers and sterilized materials)
  • Supervising of (direct report) employees. This includes accountability for the performance and results of the direct reports and accountability for teamwork
  • Insure that the manufacturing of uniQure’s therapeutic products are realized and documented in the most efficient and effective way and according to the highest industrial and GMP quality requirements
  • Perform the manufacturing of uniQure’s therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements
  • Keep the manufacturing activities up-to-date in order to meet uniQure’s production needs in terms of timing, quantity, quality, safety, health and environment
  • Collaborates with Process Development to facilitate development and qualification of manufacturing steps, allowing manufacturing of products with proven efficacy and safety
  • Transfer developed manufacturing steps from Process Development to Manufacturing, responsible for subsequent generation of GMP manufacturing documentation, systems and validation; to allow manufacturing and release of products for clinical use
  • Interact with the Quality Control department for the planning of testing activities
  • Interact with the Quality Assurance department to manage document review/approval planning and ensures compliance with GMP
  • Organizing a robust communication line to all other relevant functions of the organization
  • Responsible for managing direct reports, including appraisals and personnel actions

Qualifications:

  • Bachelor of Science in Biology, Pharmacy, Biotechnology, Chemistry or equivalent through experience. At least 2 years of relevant working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
  • Proven experience in guidance/supervision of a functional group (several technicians ranging from junior to senior level)
  • Knowledge of company internal and regulatory (FDA) policies, processes and procedures
  • Hands-on experience in writing and reviewing regulatory compliant documentation
  • Experience in (bio)-manufacturing performance, verification and validation, preferable in the area of biologics, especially gene therapy or vaccines
  • Experience with supervision of contract manufacturers maintaining contracts and monitoring of external manufacturing performance work
  • Has advanced and specialized expertise, typically developed through a combination of job-related training and considerable on-the-job experience
  • Good verbal and written communication skills
  • Comfortably able to lift up to 40lbs

Core competencies:

  • Has process-oriented way of thinking and working and good planning and organizing skills
  • Is detail oriented
  • Is able to communicate in professional way on diverse levels and channels
  • Has a flexible attitude in a challenging environment
  • Is intrinsically motivated and sensitive to the need of others
  • Ability to explain complex technical issues, question and answers in writing and orally to persons not familiar with the subject
  • Ability to steer a team and good coaching skills
  • Bring together and maintain conjunctions with other departments
  • Signals problems, recognizes important information, traces possible causes of problems and brings forward original solutions
More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Biotechnology
Region United States
Keywords Manufacturing

Contact information

Name Jennifer Wagner

Location

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