uniQure

Scientist Formulation Development in Amsterdam (NL) - Amsterdam

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Active since 25-05-2018 Job category Science, research & development
Location Amsterdam Level Mid-Senior level
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Based in Amsterdam and Lexington (USA), uniQure is a biotech company dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high medical need.

Due to an increased workload there is an immediate requirement for an experienced Scientist Formulation Development in Amsterdam to join our company.

The role:

uniQure’s gene therapeutic vectors are complex biological products that are subject to extensive quality testing before they are release for purpose. You will be responsible for development activities pertaining to uniQure’s gene therapy drug products throughout their lifecycle.

Your core tasks are to:

  • Design, execute and report formulation, stability, compatibility and exploratory characterization studies.
  • Establish any required analytical methodology needed for characterization of new formulations.
  • Support related functional areas (Research, Vector Development, Analytical and Process Development, Non-Clinical and Clinical Development as well as Manufacturing) on drug product related topics e.g. (pre)formulation studies, diluent compatibility, device compatibility, implementation of new formulations.

The role also includes (internal) reporting of formulation, stability, compatibility, and product characterization studies as well as contributing to regulatory submissions (IMPD, IND, dossier variations).

Overall, your will play an important role in implementing uniQure’s formulation platform and increased understanding of the physicochemical attributes of uniQure’s new gene therapy products, from the pre-clinical development phase up to market authorization.

Your responsibilities:
  • Design, plan, supervise and report formulation, stability, characterization, and compatibility studies (includes hands-on time)
  • Timely and adequate reporting of study results
  • Support Process Development, Analytical Development and Manufacturing on Drug Product related topics (e.g. physicochemical characterization, new formulation implementation, evaluation of stability-indicating product quality attributes, early/supportive evaluation of product stability) throughout product lifecycle
  • Support Non-Clinical and Clinical Development on compatibility topics (e.g. diluent, plasma, device compatibility studies)
  • Contribute to regulatory submissions (IMPD, IND, dossier variations)
  • Explore and establish novel analytical methodologies to characterize the product from a physicochemical viewpoint

You will need:

  • A PhD or MSc in a Life sciences-related field with affinity for analytics (HPLC, spectrophotometry, molecular biology...) or proven equivalent industry experience.
  • A proven scientific or technological background (publications, specific experience)
  • 2 years of relevant working experience in a comparable position, preferably in an industrial organization
  • Affinity with hands-on work (i.e. willingness to work in the laboratory)
  • Affinity with physicochemical characterization of biologics preferably recombinant viruses
  • To understand of Process Development of biological products
  • To have knowledge of regulatory policies and guidelines regarding stability (ICH, compendia (Ph. Eur., USP))
  • Familiarity with Good Manufacturing Practices in the biotechnological or pharmaceutical industry
  • Integrity, accuracy, a proactive attitude
  • Strong analytical skills, an strong affinity with (and keen interest in) raw analytical data are a prerequisite
  • Planning and organizing capabilities: to be able able to plan multiple ongoing studies simultaneously.


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 fun and inspiration; a generous education budget; a discount on fitness and a very nice, brand new lab and office space.


More information
This listing is a full-time job

Job category Science, research & development
Industry / Industries Biotechnology
Region Netherlands
Keywords

Contact information

Name Marsha Lemmers

Location

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