(Senior) Technician AD
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 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 (Senior) Technician Analytical Development will be part of the Analytical development function within the CMC Development Department. The (Senior) Technician will be focusing on the execution and reporting of laboratory activities. The core tasks will be focused on planning and performance of laboratory work, data analysis trending, and reporting, SOP/Documentation writing, plan and execute troubleshooting and assay transfer activities.
Place in the Organization
The CMC Development department is embedded within Technical Operations and consists of Drug Substance Development (DSD), Drug Product Development (DPD) and Analytical development (AD). The team operates closely with Research, Non-Clinical and Clinical Development providing early support to projects entering the development pipeline, up to lifecycle management of commercial products. The (Sr.) Technician will be a contributor to the activities of the AD group with specific attention toward the core focuses of the AD group:
i) Providing analytical support to DSD and DPD (Process Development) activities by ensuring consistent and timely execution of standardized platform product characterization assays, including data review, storage and trending.
ii) Developing, qualifying and transfer of product-specific assays to be used for release testing, stability testing, and extended characterization.
iii) Integrating new program products into uniQure analytical platforms, to ensure timely progress of transfer and regulatory filing efforts.
The (Senior) Technician reports to the Analytical Development Team Leader.
Key result areas (major duties, accountabilities and responsibilities)
- Execute experiments in presence or absence of formalized and structured instructions (e.g. SOPs and protocols) to support optimization, qualification, and transfer
- Design experimental plans under the supervision of a scientist to support development, qualification and troubleshooting of assays, as well as introduction of new analytical technologies
- 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
- Perform laboratory associated tasks (e.g. buffer preparation, aliquoting of materials, ordering, maintenance) according to best laboratory practices
- 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.
- Notify superior of all observed deviations in a timely frame and provide input on the possible cause of the deviation and proposed remediation plan.
- Independently plan own laboratory work to ensure maximum efficiency while ensuring alignment with overarching deliverables and laboratory resource utilization (e.g. use of lab equipment)
- Assist (junior.) Technicians with their planning and coordination of daily activities
- Coordinate planning, scheduling activities of (junior) technicians within the team communication and alignment with internal stakeholders.
- Write laboratory and technical documentation relevant to or resulting from routine testing (SOPs), writing documents for development, qualification and transfer activities (protocols, reports) under supervision of a scientist
- Execute activities within his/her area of expertise and experience. Develop new skills and knowledge necessary to successfully support assigned tasks and projects through training and independently. Continuously improve and update her/his area of expertise.
- Train (junior) Technicians, QC analysts or other players as part of the technology transfer and qualification activities
- Provide improvement suggestions and support the improvement implementation.
#LI-EB1
- BSc with 4-6 years of experience, or MSc with 2-4 years of experience in a Life Sciences-related field (biochemistry, molecular biology, biotechnology)
- Extensive knowledge of aseptic techniques 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)
- Experience in assay development and trouble shooting
- Experience in viral vaccines or gene therapy is a plus
- Working experience in a regulated setting (GxP), technical documentation writing (SOP, Protocols, Reports), and awareness of GxP pharmaceutical regulations
- Computer software skills including Microsoft Office
- Strong interpersonal and communication skills in English, written and verbal including presentation of technically complex data