(Senior) Manager – Quality Control (m/f/d)

Qualitätskontrolle

HOOKIPA Biotech GmbH

Wien

(Senior) Manager – Quality Control (m/f/d)

HOOKIPA Biotech GmbH

Qualitätskontrolle

Wien

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:

We are looking for a well-structured and organized (Senior) Quality Manager with a focus on quality control for HOOKIPA’s pipeline products. This function should bring along a well-founded GMP experience and good understanding of regulatory requirements relevant for quality control including interpretation of the guidance documents. A strong analytical background is required to support method validation at external partner labs and troubleshooting during GMP release testing and stability. Working closely with HOOKIPA’s CMC team as well as the analytical team to execute on program initiatives and deliverables to accomplish the company’s milestones is part of the responsibilities of this position.

 

Main Responsibilities:

  • Act as an expert leader in the CMC teams by advising and guiding the cross-functional team through key QC-related issues
  • Quality control representative for program-related internal and external (joint) CMC meetings
  • Manage and process QC owned deliverables to support project milestones
  • Cooperation and management of QC testing labs to support timely delivery of GMP release testing and stability results
  • Data review, entry and data trending including data compilation and analysis
  • Review of QC owned sections for regulatory submissions
  • Managing and processing of change controls, OOx investigations, and deviations
  • Work closely with QC testing labs to assure GMP compliant and timely execution of QC method validations and support analytical laboratory investigations during method validation
  • Ensure QC requirements are met over life cycle for specifications and method validation and verification
  • Optimize the effectiveness of the Quality System to meet applicable regulatory requirements

 

 

 

Qualifications & Skills:

  • University degree in natural sciences or equivalent technical discipline required, ideally in Biochemistry, Biotechnology or Pharmacy
  • Minimum 5 years of industry experience in the pharmaceutical/biotech industry
  • Strong experience in Quality Control and quality systems (OOS/OOE investigations, deviations, CAPAs and change controls)
  • Profound biotechnological and pharmaceutical understanding
  • Hands-on knowledge of EU GMP regulation
  • Ability to work in a team environment as well as independently with a proactive working style and ability to prioritize and multi task
  • Competent in generating and sharing knowledge within the QC-team and also in cross-functional teams
  • Strong verbal and written communication skills (fluent in English is a must)
  • Competence in Microsoft Office Tools
  • 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.com

 

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