(Sr) Scientist Analytical Development - Bioassays
uniQure is dedicated to bring innovative 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 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 (Sr) Scientist Analytical Development will be part of the Analytical Development (AD) group. The (Sr) Scientist focuses on defining and managing the execution of the bioassay (potency) development strategies and activities across the product lifecycle through in depth understanding of the product properties and TPP (Target Product Profile), aligned with AD function and CMC team.
The (Sr) Scientist owns the bioassay (potency) development lifecycle both from a technical and planning stand point. Responsibilities will include scientific and operational responsibility of assay design, development, qualification, troubleshooting, and transfer.
Place in the Organization
The AD Group is embedded within the Product Development department within Operations. The (Sr) Scientist will be a contributor to the focus area of Analytical Development Team:
- Developing, qualifying and transferring product-specific assays to be used for release testing, stability testing, and extended characterization, including Control strategy, critical material assessment, and proposal of trending strategy.
- Integrating new products into uniQure analytical platforms, to ensure timely progress of transfer and regulatory filing efforts.
The (Sr) Scientist reports to the (Sr)Director Analytical Development.
Key result areas (major duties, accountabilities and responsibilities)
- Design and drive experimental plans underlining development, qualification, transfer and troubleshooting of bioassays (potency) in line with CMC and regulatory requirements
- Plan and execute experimental campaigns with support by technicians. Prepare data overview and reports. Define development strategy and timelines
- Draft and review laboratory and technical documentation relevant to assay execution (Electronic Lab Notes, SOPs), assay development, qualification, transfer, troubleshooting or other AD relevant studies (protocols, reports, position papers and memos)
- Assist team members with their planning and coordination of daily activities
- Communicate and align with internal and external stakeholders including CMC on AD activities relevant to specific projects planning and progression.
- Communicate and align with internal and external stakeholders activities relevant to specific project planning and progression.
- Support technicians, QC analysts or other players as part of the technology transfer and qualification activities
- Ensure all laboratory activities are performed according to applicable procedures to ensure a safe working environment and high data quality
- Provide improvement suggestions and support the improvement implementation.
Qualifications & Skills
- Minimum of MSc with 8 years (10 for Sr Scientist) of experience or PhD with 4 years (6 for Sr Scientist) industrial experience in a Life Sciences-related field (biochemistry, molecular biology, biotechnology)
- Extensive hands-on knowledge of bioassay (potency) design, development, statistical assessment, qualification, and transfer in pharmaceutical industry, including in depth operating knowledge of testing in development and GMP setting
- Demonstrated experience in project leadership skills including setting and driving timelines through own and team members activities
- Broad experience in technical documentation writing and reviewing (SOP, protocols, reports, IND/IMPD/BLA sections)
- Thorough understanding of pharmaceutical regulations (ICH, USP) applicable to bioassays (potency) development and qualification in Europe and USA from early clinical to commercial stage (including analytical method lifecycle)
- Thorough scientific knowledge and hands on experience with relevant molecular biology techniques (e.g. (q)PCR, DNA electrophoresis)
- Thorough scientific knowledge and hands on experience with biochemical analyses (e.g. protein electrophoresis, western blotting, ELISA)
- Strong experience in setting timelines within a project planning, alignment and helping others to meet timelines
- Experience in cell and gene therapy highly preferred
- Strong interpersonal and communication skills written and verbal including presentation of technically complex data to both technical and executive audiences.
- Detail oriented: strong analytical skills, strong 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 within multiple projects (e.g. results achieved according to self-prepared protocols, results compiled in clear overview and proposal including timelines for follow up experiments)
- Analytical Thinking and Problem Solving : Strong ability to signal problems, recognize important information, trace possible causes of problems, think about and implement new working methods or new applications, bring forward and implement original solutions for problems related to the department and function and help others in signaling problems and implementing solutions
- Planning and organizing: Strong ability to plan own and other’s work to achieve results in a timely way while ensuring the highest standard of quality, including ability to foster team productivity and cohesiveness in a fast-paced environment
- Co-operative: Strong ability and drive to work within an interdisciplinary (project) team, good written and spoken communication skills, ability to communicate and align with internal stakeholders and CMC team, ability and willingness to work in a fast-paced environment. Self-aware.
- Soft Skills: Dependable, proactive, motivated, flexible