Manager Quality Control (m/f/d)
HOOKIPA Biotech GmbH
Wien, Wien, Österreich
vor 4 Std.
source : Karriere

Manager - Quality Control (m / f / d) Date posted : July, 2022Location : Vienna, Austria About HOOKIPA : HOOKIPA Pharma Inc.

NASDAQ : HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T cells to address unmet needs in cancer.

This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics.

These novel immunotherapies induce robust antigen-specific killer T cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens.

HOOKIPA's platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T cell response levels previously not achieved by other immunotherapy approaches.

HOOKIPA's pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects.

In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead. Position Summary : This position focuses within Quality Control on the goals and deliverables of HOOKIPA's clinical programs .

The incumbent should act as the solely go-to function for the CMC program management concerning Quality Control topics.This position is part of the Quality Management (QC) group at HOOKIPA and reports directly to the Head of Quality Control.

In addition to all other parts of QC this position has day to day interaction with HOOKIPA key functions, such as CMC Program Management, External Manufacturing, Project / Portfolio Management, Process Development, Analytical Development and Regulatory Affairs. Main Responsibilities :

  • Provide overall guidance of all Quality Control functions relative to their contribution to the Hookipa programs
  • Continuously plan, review, and revise the Quality Control relevant parts of the project plan (in close cooperation with HOOKIPA program manager and non-Quality Control functions towards the benefit of the project)
  • Closely monitor the development of all applicable parts of the project, identify Quality Control implications and develop / decide on actions as well as appropriate priorities to make the project run smoothly. This includes in particular
  • CMO / CLO oversight
  • QC representative in internal and external (joint) CMC teams
  • sample prioritization and testing coordination
  • data evaluation and presentation
  • Processing and handling of program related OOS, Deviation and Change Controls
  • Provide regulatory writing for QC-owned CMC parts of clinical trial applications (IB, IND, IMPD etc.)
  • Contribute to continuous improvements and process optimization of HOOKIPA's Quality Management System Qualifications & Skills :
  • University degree in natural sciences or equivalent technical discipline required, ideally in Biochemistry, Biotechnology or Pharmacy
  • Strong experience in Quality Assurance and / or Quality Control
  • Profound biotechnological and / or pharmaceutical understanding
  • Substantial experience in managing research cooperation projects with a specific Quality Management focus (ideally experience within clinical development, clinical research and clinical trial environment in the biotech area)
  • Particular knowledge of recombinant virus vector technology or live attenuated virus vaccines a strong plus
  • Thorough knowledge and capability of interpretation and applicability of GxP regulations and standards, internal GxP guidelines, cGMP 21 CFR 210 / 211 / 600 / 820 and Eudralex Volume 4 GMP guidelines, ICH Quality guidelines, USP and European Pharmacopeia
  • Fluency in English, both spoken and written
  • Valid EU working permit What we offer :
  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Employee benefits such as health screening, public transportation card, Sodexo pass
  • Working in a multinational and multicultural environment We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 4.
  • 112, - based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

    Starting date : as soon as possible Contact : If you (m / f / d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to : talent hookipapharma.

    comFor more information on HOOKIPA please visit www.hookipapharma.com

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