Senior Manager - External Partnerships (m/f/d) (Temporary Substitution for Parental Leave - 40h/week)

Position Summary

As part of the Drug Supply & External Partnerships team, you will be responsible for developing and managing key external partnerships with CDMOs, CLOs and other strategic partners to advance HOOKIPA’S drug development programs. You will manage outsourced GMP supply campaigns and be responsible for the planning and successful execution of external GMP operations. You will work in a highly cross-functional environment, effectively collaborating with CXOs/external partners as well as internal Subject Matter Experts, including Process Science & Technical Services, Quality Assurance, CMC Program Management, Regulatory Affairs, Finance and Legal.

• Act as Technical Project Leader and Business Partner for Contract Manufacturing and/or Laboratory Organizations:
  • Own ongoing relationships with external partners, including regular communication, issue resolution, performance tracking and improvement initiatives
  • Establish project plans, timelines, and budgets to ensure successful execution
  • Manage day-to-day operations with the CXO; coordinate all activities between internal departments and the CXO (e.g. deviations or other critical activities)
  • Support the qualification and onboarding of new suppliers, be part of contract setting with the partner company
• Lead creation, contribute to or review GMP documents (e.g. manufacturing instructions, process descriptions, deviations, change controls etc.)
• Lead projects related to outsourced drug development at external partners (non-GMP), in collaboration with internal HOOKIPA teams
• Support IND/IMPD submissions and other CMC regulatory documents by preparing, collecting and reviewing critical documents necessary for submissions

Qualifications

• At least 7 years work experience in the biotechnology industry
• Scientific/technical expertise in at least one key area of CMC development
• GMP experience and knowledge of ICH guidelines
• Basic understanding of quality assurance
• Late-stage CMC development and/or commercial experience would be advantageous
• Lean Six Sigma (or similar) qualification would be advantageous
• Excellent communication, teamwork, and leadership skills
• Strong project management skills
• Ability to work independently in a fast-paced, dynamic environment
• Very good command of English (B2 level or higher)
• Master´s degree in Life Sciences, Biotechnology or a comparable field

If you are a driven, results-oriented individual who thrives in a fast-paced, dynamic environment, we encourage you to apply for this exciting opportunity to join our growing team.

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 4.828,- 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. The position is a temporary replacement (Karenzvertretung) and is expected to last until 31.12.2024.

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