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Analytical Support Supervisor

 Location:   Amsterdam (Netherlands)   
 Job category:   AD - Product Analyt Dev't   

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

Purpose of the role

The Analytical Support Supervisor will be part of the Product Analytical Development (PAD) group. The Analytical Support Supervisor will focus on planning, execution and reporting of laboratory activities. The core tasks will be focused on planning, designing, executing and reporting experimental work, data analysis trending, and reporting, SOP/Documentation writing.

Place in the Organization

The PAD Group is embedded within the Analytical Development department, which also consists of Bio-Analytical Development (BioAD), and Drug Product Development (DPD). The Analytical Support Supervisor will be a contributor to the activities of PAD group with a specific attention toward the critical activities of the PAD group:

  1. Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
  2. Providing analytical support to DPD and PD (Process Development) activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending.
  3. Integrating new program products into uniQure analytical platforms, to ensure timely progress of transfer and regulatory filing efforts.

The Analytical Support Supervisor reports to the Analytical Development Senior Scientist /Team Lead.

Key result areas (major duties, accountabilities and responsibilities) 

  • Independently plan own and team laboratory work to ensure maximum efficiency while ensuring alignment with overarching deliverables and laboratory resource utilization (e.g. use of lab equipment)
  • Coordinate planning, scheduling activities of technicians within the team communication and alignment with internal stakeholders.
  • Executes experiments and prepare data overviews and reports, including interpretation of results. Suggest next steps in experimental design including rationale for suggestions
  • Drafts and reviews laboratory and technical documentation relevant to assay execution (Electronic Lab Notes, SOPs), assay development, qualification, transfer, troubleshooting or other PAD relevant studies (protocols, reports, position papers and memos)
  • Collect, and store experimental data sets and document analytical results to ensure maximum traceability
  • Prepare data overviews and reports, including interpretation of results. Suggest next steps in experimental design including rationale for suggestions
  • Ensure training of technicians on relevant analytical methods and laboratory and data recording practice
  • Ensure all laboratory activities are performed according to applicable protocols, and follow safety and quality procedures to ensure a safe working environment and high data quality
  • Notify superior of all observed deviations in a timely frame and provide input on the possible cause of the deviation and proposed remediation plan.
  • Improvement of skills and knowledge necessary to successfully support assigned tasks and projects through training and independently. Continuously improve and update her/his area of expertise.
  • Provide improvement suggestions and support the improvement implementation.

 

Qualifications & Skills

  • Minimum of BSc in a Life Sciences-related field with 10 years or MSc with 4-6 years of working experience in a biotech or pharma company .
  • Extensive knowledge and hands on experience with aseptic cell culture techniques (e.g. insect and human cells)
  • Extensive knowledge and hands on experience with relevant molecular biology techniques (e.g. (q)PCR, DNA electrophoresis)
  • Extensive knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)
  • Solid experience in supervising and motivating a team of technicians and organizing laboratory activities in a clear and structured way
  • Experience in assay design and trouble shooting
  • Solid experience in writing technical documentation (SOP, Protocols, Reports) and review of analytical data and laboratory notebooks (e.g. ELN)
  • Working experience in a regulated setting (GxP) and awareness of GxP pharmaceutical regulations is highly recommended
  • Experience in viral vaccines or gene therapy is a plus
  • Computer software skills including Microsoft Office
  • Strong interpersonal and communication skills in English, written and verbal including presentation of technically complex data

Core competencies

  • Detail oriented: strong analytical skills, high level of understanding of assay principles, ability to critically analyze and present complex data sets
  • Thorough: ability to set up and carry out tasks with an eye for completeness (e.g. results achieved according to self-prepared protocols, results compiled in clear overview and proposal for follow up experiments)
  • Analytical Thinking and Problem Solving: signals problems, recognizes important information, traces possible causes of problems, thinks about and implements new working methods or new applications, brings forward and implements original solutions for problems related to the department and function
  • Planning and organizing: ability to plan own and other’s work to achieve results in a timely way while ensuring the highest standard of quality, discuss with others to align planning of multiple complex activities simultaneously, scheduling activities with technicians within the team and help team members with their planning. Ability to effectively adapt and support re-prioritization of activities and goals in a fast paced environment
  • Co-operative: ability and drive to work within and across teams, good written and spoken communication skills, ability and willingness to work in a fast-paced environment. Self-aware.
  • Soft Skills: dependable, proactive, motivated, flexible