(Junior) Manager CMC Lead – CMC Program Management

Position Summary

As a CMC Lead, you will lead a cross-functional team which is responsible for all CMC relevant aspects for a specific pipeline program. You will be responsible for organizing the CMC sub-team meetings for your program (including also meeting documentation, responsibility for the meeting culture). You will be responsible for CMC program / project planning, monitoring, and controlling in terms of project scope, timelines, regulatory compliance, budget, resources, and risk management. You represent Technical Development in cross-functional program core teams. You take responsibility for the collection and distribution of CMC-related information across teams and facilitate cross-functional communication.

• Manage collection and distribution of information for all CMC related topics and ensures that all relevant information is communicated to the Program Manager, program core team members, the CMC sub-team members, and the Head of CMC Program Management (CMC PM HoD).
• Lead the CMC subteam for a given pipeline program (including meeting organization and preparation of documentation)
• Manage program-related projects and keep an overview on all open and upcoming items.
• Drive and facilitate decision making in the CMC space or take a final decision in compliance with Hookipa governance if an alignment cannot be reached.
• Drive cross-functional communication and implement a steady information flow.
• Align with CMC sub-team members to ensure CMC timelines, budget and resources are meeting overall program requirements.
• Drive identification of project risks or bottlenecks and lead the design of mitigation strategies.
• In case of conflicts, align with CMC sub-team members, and assess the impact on regulatory or supply strategy as well as project timeline and costs.
• Plan and oversee writing and reviewing of documents for INDs / regulatory section submissions.
• Ensure preparation and review of CMC regulatory and quality relevant documents.

Qualifications

• At least two years of experience in the pharmaceutical industry
• At least two years of experience in project / program management
• Strong background in biotechnology
• Self-motivated with a great sense of ownership in the area of responsibility
• Great time-management, ability to perform very well under time pressure
• Great presentation skills, communicative personality
• 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 3.643,- (Junior Manager) or EUR 4.112,- (Manager) 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