(Senior) Specialist Stability Studies- Quality

vor 3 Wochen

Wien, Österreich HOOKIPA Biotech GmbH Vollzeit

**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**:
The QC Specialist manages program-specific stability studies, oversees stability related activities and ensures timely execution at external contract laboratories. Monitoring and analyzing data as well as summarizing the results and conlusion in a report are also part of this function.

**Main Responsibilities**:

- Management of Stability Studies for Drug Products, Drug Substances, and Intermediates stored under several conditions (long-term, accelerated studies, In-Use stability studies)
- Generation of Stability Protocols and Reports
- Ensuring timely testing of stability samples within the analytical test window at external contract laboratories
- Data monitoring and trending as well as statistical analysis
- Support evaluation of shipping and handling excursions
- Ownership of OOS/OOE events, deviations and changes with regards to stability
- 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 Control and/or Quality Assurance
- Profound biotechnological and/or pharmaceutical understanding
- Particular knowledge of stability studies with gene therapy products is a strong plus
- Hands-on knowledge of EU GMP regulation
- Experience with quality systems (OOS investigations, deviations, CAPAs, and change controls)
- Competence in Microsoft Office Tools
- Fluent 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 2.754;
- (Specialist) 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**:

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