uniQure

Sr. Scientist AD - Phase I-II Analytics - Amsterdam

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Job

Active since 20-04-2018 Job category Production (Operators)
Location Amsterdam Level Mid-Senior level
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The vacancy:

We are currently looking for an experienced (Senior) Scientist Analytical Development – Phase I product analytics. Do you have a PhD in a Life Sciences-related field with affinity for analytics (Molecular biology, HPLC, MS) and at least 5 years of within the pharmaceutical or (biotech) industry? Please apply now!

About uniQure and the Analytical Development department:

uniQure is dedicated to bringing 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 (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

Analytical Development is covering important areas in generating value of uniQures’ AAV-based gene therapy products. First, the department is responsible for developing and implementing product specific assays to ensure the quality of uniQure’s products. Second, the department develops and implements assays to monitor function and safety of uniQure’s products during non-clinical development, and provides support during clinical development and beyond MAA. Finally, the development operates closely with the Process Development (PD) department, providing the analytics needed for further optimization and development of uniQure’s AAV production platform.

More about the role:

uniQure’s gene therapeutic vectors are complex biological products that are subject to extensive quality testing before they are released for purpose. The Scientist Analytical Development – Phase I product analytics is responsible for establishing analytical methods to support quality testing of uniQure’s gene therapy products up to, and including, the Phase I/II clinical stage. The core tasks of the scientist are to:

  • Develop and qualify (bio)assays to support product quality testing of uniQure’s gene therapeutic vectors
  • Implement these assays into routine testing of development- and non-clinical-grade materials
  • Monitor assay performance, tweak and troubleshoot
  • Support transfer of the assays to a QC environment

Responsibilities include the (internal) reporting of assay development, qualification and validation results, as well as contributing to regulatory submissions (IMPD, IND, dossier variations).
Overall, the Senior Scientist Analytical Development – Phase I product analytics will play an important role in establishing product-specific assays to ensure the quality of uniQure’s new gene therapy products, from the pre-clinical development phase up to market authorization. The Scientist is also managing a team.

Responsibilities (include but are not limited to):

  • Design, plan, and supervise assay development, qualification and validation (includes hands-on time)
  • Timely and adequate reporting of assay development, -qualification and -validation results
  • Overseeing of assay performance during early stages of assay life cycle (trend, tweak and troubleshoot)
  • Support of assay transfer to the QC environment during subsequent stages of assay lifecycle (validate, support, troubleshoot)
  • Review of analytical results and data obtained during non-clinical and early clinical phase
  • Contribute to regulatory submissions (IMPD, IND, dossier variations)
  • Explore novel analytical tools to update the analytical package (i.e. perform product characterization using state-of-the-art techniques)
We are looking for a colleague with:
  • A PhD in a Life Sciences-related field with affinity for analytics (Molecular biology, HPLC, MS)
  • Proven scientific or technological background (publications, specific experience)
  • Affinity with hands-on work (i.e. willingness to work on the lab floor)
  • Affinity with (bio)-assay development, qualification and validation, preferable in the area of gene therapy or vaccines
  • Knowledge of regulatory policies and guidelines (ICH; compendia (Ph. Eur, USP); EMA; FDA)
  • Preferably proven GMP experience
  • Experience in a similar position (similar type of work, similar group dynamics)
  • Proven experience in managing technical staff

What we have to offer:

Beyond a competitive remuneration package, working at uniQure brings many perks and exciting opportunities. How about a very international workforce; a work environment that offers room for intellectual challenges and inspiration; a generous education budget; a discount on fitness and a very nice, brand new office.

More information
This listing is a full-time job

Job category Production (Operators)
Industry / Industries Biotechnology
Region Netherlands
Keywords Analytical Development

Contact information

Name Marsha Lemmers

Location

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