Scientist Clinical Bioanalytics

uniQure; Amsterdam; On-site; EUR 70,000 - 100,000; Full time

Job summary

uniQure is seeking a skilled Bioanalytics professional to strengthen our Clinical Bioanalytics team. You will focus on pharmacodynamic aspects of gene therapy studies, developing and validating PK/PD and biomarker assays, and ensuring GLP-compliant reporting.

Collaborating with Disease Biology, Non-Clinical and Clinical Development groups, you will oversee CROs, transfer methods, and establish robust analytical documentation to support clinical programs.

Qualifications

• PhD in a life-sciences field with at least 2 years in a life-science company.
• Experience overseeing CROs.
• Familiar with regulatory guidelines on assay development/validation (ICH, Ph. Eur, USP; EMA; FDA).
• Good Laboratory Practices (GLP) experience.
• Experience in PK/PD/ biomarker assays, preferably in biologics or gene therapy.
• Knowledge of diverse lab techniques: enzymatic activity, ELISA, MSD, SMC, Immuno-PCR.
• Excellent English (spoken and written).
• Strong written and verbal communication skills.

Responsibilities

• Transfer established bio-analytical methods to CROs for validation under GLP/regulatory compliance.
• Oversee analytical phase of clinical studies.
• Deliver analytical phase reports for clinical studies.
• Establish analytical documentation (procedures, development and validation reports).
• Lead/support technical analytical staff; may perform hands-on lab work.
• Evaluate new technologies as potential biomarker assay platforms.
• Support knowledge base on assay development, validation and regulatory guidelines.
• Support selection and contracting of CROs.
• Collaborate with technical analytic staff across departments.
• Represent Clinical Bioanalytics among other functions.

Skills

CRO oversight

GLP experience

Scientific background

English proficiency

Communication skills

Lab techniques

Education

PhD in life sciences

Tools

ELISA

MSD

Immuno-PCR

Simoa

Job description

Job Description

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.

• 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