6 beste vacatures voor de functie van lead technician in amsterdam, nh (nieuwe medewerkers gezocht)

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Scientist Clinical Bioanalytics

uniQure -
Amsterdam

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Vacaturegegevens

3 dagen geleden

Kwalificaties

Doctor
Laboratoriumervaring
Engels
Analytisch vermogen

Volledige vacaturetekst

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

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lead technician vacatures in amsterdam, nh

Scientist Clinical Bioanalytics

Mechatronics Engineer

Senior Mechanical Engineer

Simulator Technician-1

Reliability Engineer

Service Technician

More jobs to discover

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van lead technician in amsterdam, nh

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