Scientist Clinical Bioanalytics

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

Key Result Areas (major Duties, Accountabilities And Responsibilities Clinical Bioanalytics is a functional group within the Clinical Operations Department, with the main responsibility to support the safety and efficacy readouts for the Clinical Programs. This task is achieved by the development, qualification, validation and implementation of bio-analytical methods that are used to monitor product efficacy (biological activity) and product safety.

You will form one of the key pillars within Bioanalytics where you will focus primarily on the pharmacodynamic aspects of our gene therapy studies using PK/PD /biomarker assays. The team works closely with other units within Clinical Operations and with other Departments within Research & Development such as the Disease Biology groups, Non-Clinical and Clinical Development.

Key Result Areas (major Duties, Accountabilities And Responsibilities)

• To transfer established, or support the establishment of, bio-analytical methods to contract research organizations (CROs) for validation under GLP and regulatory compliance
• To oversee the analytical phase of clinical studies
• To deliver (or ensure delivery of) analytical phase reports for clinical studies
• To establish relevant quality documentation (analytical procedures, analytical development reports, analytical validation protocols and reports, including external protocols and reports on outsourced studies)
• If required, to support and lead technical analytical staff; this includes accountability for their performance and results and may also require hands on lab work
• Evaluate new technologies as potential novel biomarker assay platforms
• To support the knowledge base around assay development and validation and current regulatory guidelines
• To support the selection and contracting of contract research organizations
• To support and collaborate with the technical analytical staff, e.g. Technicians, Research Associates
• To represent Clinical Bioanalytics towards all other relevant functions within the organisation

Qualifications & Skills

• PhD in a life-sciences related field with minimum 2 years’ experience in a life-science based company, preferably in the field of (bio-) pharmaceuticals, gene therapy and/or vaccines
• Previous experience with CRO oversight
• Affinity with regulatory policies and guidelines on assay development and validation (ICH, compendia (Ph. Eur, USP); EMA; FDA)
• Active experience with (working under) good laboratory practices (GLP)
• Demonstrated scientific background, with focus on central nervous system indications, and preferably within a clinical context
• Experience in developing PK/PD/ biomarker assays, preferably in the area of biologics, preferably gene therapy or vaccines
• Familiarity with a broad spectrum of laboratory techniques, such as Enzymatic activity assays, ELISA, MSD, and cutting-edge technology immunoassay platforms such as SMC, Simoa and Immuno-PCR
• Excellent knowledge of the English language (verbal, written and scientific)
• Excellent communication (oral and written) skills

uniQure is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital status, veteran or military status, or any other characteristic protected by applicable federal, state, or local laws. If you need assistance or a reasonable accommodation during the application process, please contact careers@uniqure.com. uniQure posts all open positions exclusively on our official Careers page and LinkedIn. We do not recruit through any other job boards, third-party websites, or unsolicited outreach via text or messaging apps. All legitimate communication from uniQure’s Talent Acquisition team will come from an @uniqure.com email address. We will never request financial information nor payment of any kind during the application process. If you receive suspicious outreach claiming to be from uniQure, do not respond or share personal information. Inquiries can be made via careers@uniqure.com. uniQure processes personal data submitted through this application for recruitment and hiring purposes only. Depending on your location, you may have specific rights regarding your personal data. For full details on how we collect, use, store, and protect your information — including disclosures for California residents under the CCPA and for applicants under the GDPR — please review our applicant privacy notice.