Pharmaceutical Scientist - Immunotherapy, Cell Therapy (Pharmazeut/in)

Gemeinsam. Fortschritt. Gestalten.

Die CureVac Manufacturing GmbH, eine 100-prozentige Tochter der CureVac SE, ist ein biopharmazeutisches Produktionsunternehmen, das neuartige Medikamente auf Basis des Botenmoleküls Messenger RNA (mRNA) herstellt. Unsere Schwerpunkte liegen auf prophylaktischen Impfstoffen, innovativen Krebsimmuntherapien sowie proteinbasierten Therapien. Aktuell engagieren sich alle RNA people dafür, unser großes Ziel zu erreichen: Wir wollen mehrere Best-in-Class mRNA-Arzneimittel auf den Markt bringen.

Zur Unterstützung unseres Teams am Standort Tübingen bei Stuttgart suchen wir zum nächstmöglichen Zeitpunkt Sie in der Position als
Quality Assurance Manager (w/m/d) Shopfloor

Quality Oversight in der Produktion von mRNA-basierten Wirkstoffen für klinische Prüfungen und Erstkontakt für die operative Produktionseinheit bei qualitätsrelevanten Ereignissen
Bearbeitung, Bewertung und Überwachung von qualitätssicherungsrelevanten Prozessen und Ereignissen (z. B. Änderungen, Abweichungen, Ursachenanalysen, CAPAs) unter Berücksichtigung behördlicher Anforderungen sowie Patientensicherheit
Erstellung oder Prüfung von Dokumenten im Dokumentenmanagementsystem
Vorbereitung oder Prüfung Chargen-bezogener Dokumente und Etiketten
Durchführung des Batch Record Review (Prüfung der Herstelldokumentation) und Vorbereitung der Chargenfreigabe
Erfassung qualitätsrelevanter Kennzahlen
Mitwirkung bei Behördeninspektionen, Selbstinspektionen und Kundenaudits
Weiterentwicklung und Bewertung von neuen Prozessen (z. B. Risikomanagement, Harmonisierung, kontinuierliche Verbesserung)
Durchführung von Mitarbeiterschulungen
Begleitung von Projekten zur Etablierung neuer Produkte, Prozesse und Qualitätsstandards

Abgeschlossenes einschlägiges Hochschulstudium mit naturwissenschaftlichem oder ingenieurwissenschaftlichem Bezug oder eine vergleichbare Qualifikation
Mehrere Jahre praktische Erfahrung in der Qualitätssicherung, idealerweise in der biotechnologischen oder pharmazeutischen Industrie
Fundierte Kenntnisse regulatorischer Anforderungen im GMP-Umfeld
Gutes Fachwissen im Qualitätsmanagement (QM); Produktionserfahrung von Vorteil
Sehr gute Kommunikationsfähigkeit und lösungsorientierte Arbeitsweise
Hohes Maß an Flexibilität
Gute MS-Office-Kenntnisse
Fließendes Deutsch und sehr gute Englischkenntnisse
Wir bieten Ihnen eine herausfordernde und abwechslungsreiche Tätigkeit in einem innovativen und dynamischen Unternehmen, das auf Wachstumskurs ist.

Mit viel Herzblut und Verantwortungsbewusstsein arbeiten wir gemeinsam an einer medizinischen Revolution. Dabei pflegen wir ein vertrauensvolles Miteinander, das von der Offenheit für Neues und ständigem Fortschritt geprägt ist. Gegenseitiger Respekt, Verlässlichkeit und Eigeninitiative sind für uns selbstverständlich.

Gestalten Sie bei uns Ihre Zukunft - werden Sie Teil der RNA people!

Design. Progress. Together.

CureVac Manufacturing GmbH, a wholly owned subsidiary of CureVac SE, is a biopharmaceutical company producing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on innovative cancer immunotherapies, prophylactic vaccines and molecular therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.

To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a
(Senior) Director (f/m/d) mRNA Manufacturing

Ensure clinical manufacturing and industrialization of products and production process improvements as well as product portfolio extensions within the APU (Autonomous Production Unit)
Disciplinary leadership of production managers & teams for the production of mRNA active ingredients, pDNA, Master Cell banking, and formulated bulk according to GMP guidelines
Follow production plans and assure feasibility, making necessary corrective adjustments as needed
Monitoring compliance with documentation requirements according to GMP
Overseeing the qualification of premises and equipment as well as the validation of processes
Committed to and accountable for delivering and pushing for speed/excellence in execution while not compromising on quality and safety
Develop long-term manufacturing strategy servicing the product portfolio
Achieve financial targets by preparing and presenting budget proposals including yearly cost improvements (e.g., yield) and managing the APU budget
Allocate appropriate resources within the budget perimeter
Manage the APU team by understanding the big picture of the manufacturing network, connecting the dots, and giving perspective and clarity to the team
Align resource planning with Supply Chain & Quality, Program Management, Engineering, and Technical Development departments concerning stocks, equipment, staffing, activities, etc.
Maintain the working environment according to GMP & EHS standards
Share information transparently
Detect and plan training needs
Participate in career management initiatives
Serve as the official APU representative to regulators, customers (external or internal) and act as a business leader by navigating and influencing in a matrix organization
Ensure established customer specifications concerning cycle time, delivery, quality, quantity, and costs are met
Implement preventive and corrective measures in the production process to assure that compliance & customer demands are properly met
Coordinate with the quality team to meet all product standards
Drive continuous improvements in APU processes to raise quality, functionality/productivity, and to obtain CureVac & product project objectives

Completed university degree with a pharmaceutical, bioengineering or scientific background or a comparable qualification
Extensive production experience and experienced people leader (several years of team management experience) including larger teams and shift operations
Positive leadership with hands-on mentality
Experience in a regulated environment of a GMP manufacturing company, certification “Leiter der Herstellung" according to §15 AMG
Knowledge of biotechnological methods such as TFF, HPLC, and transcription is advantageous
Operational knowledge of Lean methods (Kanban, 5S, Hoshin, Daily Performance Management) and shop floor management is desirable
Ability to influence heterogeneous and diverse teams in a matrix organization
Strategic thinking, Lean Mindset and strong communication skills
Good MS Office skills and experience with process control systems are advantageous
Fluency in English and German
We offer you a challenging and varied opportunity with an innovative and dynamic company.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas...

Overview

We are currently seeking a full time Principal Scientist* to support our Global ACTallo® team. This position will work on-site in Tuebingen, Germany and will report directly to the Vice President.


Principal Scientist gamma delta (γδ) T cell Therapy*

Permanent employee, Full-time · Tübingen - Paul-Ehrlich-Straße
As the scientific lead for the development of our allogeneic cell therapy portfolio, you will guide the ACTallo® development in close interaction with the respective scientific, preclinical, and clinical teams. You will continuously broaden your already profound scientific knowledge of gamma delta (γδ) T cell based immunotherapeutic approaches and apply it to our proprietary development activities to foster innovation.

The essential functions of this position will include but are not limited to the following:



    Take responsibility for the scientific leadership of our global R&D activities on γδ T cells
    Communicate within our cross-functional teams and at the interface of collaborations as a dedicated γδ T cell expert
    Coach laboratory teams on γδ T cell specific assays, such as ex vivo expansion, phenotyping, and functional assays in the context of antitumor research
    Provide scientific guidance for γδ T cell focused preclinical research and development activities towards IND enabling
    Establish and expand a network of key opinion leaders in the field of allogeneic immunotherapy
    Initiate and lead scientific collaborations
    Become an approachable expert and consultant for the Immatics leadership team on γδ T cell development activities

    Advanced degree such as PhD/ PharmD/ MD or equivalent
    You have gained at least 7 years of professional experience in academia or biomedicine industry in the field of γδ T cell immunology, or γδ T cell immune therapy
    You have proven your scientific excellence by a profound publication record in the relevant field
    You are passionate about the proactive development and translation of our γδ T cell therapy portfolio as well as driving innovation in a biomedical company’s solid cancer indication pipeline
    Ideally, you already have a network of clinicians or researchers focusing on allogeneic immune cell therapy
    Very good communication skills, the ability to work within a cross-functional team and very good English language skills complete your profile
We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits - e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.


Notice

*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to ethnicity, color, national origin, religion, gender, age, marital status, disability, veteran status, romantic orientation, gender identity, or other characteristics protected by law.