(Senior) Cdmo Manager
vor 3 Wochen
**About HOOKIPA**:
HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, based on its proprietary arenavirus platform, which are designed to mobilize and amplify targeted T cells and thereby fight or prevent serious disease. HOOKIPA’s replicating and non-replicating technologies are engineered to induce robust and durable antigen-specific CD8+ cell responses and pathogen-neutralizing antibodies. HOOKIPA’s pipeline includes its wholly owned investigational arenaviral immunotherapies targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed programs. In addition, HOOKIPA aims to develop functional cures for HBV and HIV in collaboration with Gilead.
**Position Summary**:
Are you an experienced CMC professional with a passion for making a difference in the field of GMP manufacturing of biologics, particularly viral vectors? If so, we have an incredible opportunity for you
Join our team and take on a role that goes beyond just a job. As a CMC expert, you will actively shape relationships with Contract Development and Manufacturing Organizations (CDMO), playing a vital role in the advancement of ground-breaking therapies. You will be the driving force behind all technical aspects of the manufacturing process, ensuring excellence and compliance at every step.
Your expertise will be key to success as you take ownership of critical areas such as technology transfer, change control, handling deviations, and providing day-to-day support for technical aspects at the CDMO. Your dedication and attention to detail will guarantee that our manufacturing processes run smoothly and efficiently, delivering life-changing medicines to patients in need.
At HOOKIPA, we foster a collaborative and innovative environment where your contributions matter. As part of our Process Science and Technical Service team, you will work closely with talented individuals who share your passion for making a difference. Additionally, you will have the opportunity to collaborate with various stakeholders in an international environment, further expanding your professional network.
This is not just a job—it's a chance to be part of something greater. Join us in our mission and embrace this extraordinary opportunity to shape the future of immunotherapies
**Main Responsibilities**:
- Point of contact for all technical aspects at CDMO; including managing day-to-day tasks, support of technical teams with expert knowledge, if required Person-in-Plant services, compliance aspects.
- Technology Transfer; Conduct and oversee technology transfers to CDMOs.
- Owner of relevant Change Controls; Things are changing, and it needs to be managed, align stakeholders internally to finish processes in time.
- Contributor to Deviation Process; support Quality Management in conducting effective Deviation Management.
- Key Contributor Supplier Qualifications; Support Quality Management in assessing and rating the qualified CDMOs.
- Representative in internal Governance Body for Clinical Programs
- Willingness to travel to US and EU destinations as a person in plant to accompany critical technology transfers, etc.
**Qualifications & Skills**:
- 5+ years of experience in GMP manufacturing of complex biologics, preferably viral vectors
- Experienced in compliance aspects of manufacturing of Gene Therapy products for EU and US market.
- Experience Process Validation and Commercial Manufacturing of biologics
- Excellent leadership and communication skills
- Strong team player
- Strong planning skills
- Experience in working in global, intercultural environments.
- Excellent English language skills, written and spoken.
**What we offer**:
- Strong team with dedicated and passionate employees
- Environment that truly values scientific excellence, creativity and initiative
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
- Employee benefits such as health screening, public transportation card, Sodexo pass
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.
Starting date: as soon as possible
**Contact**:
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