Auf einen Blick
- Aufgaben: Leite innovative Biologika- und ADC-Entwicklungsprojekte und definiere Strategien für klinische Ziele.
- Unternehmen: Globale, innovationsgetriebene Pharmaorganisation mit Fokus auf bahnbrechende Medikamente.
- Vorteile: Flexible Arbeitsmodelle, starke berufliche Entwicklungsmöglichkeiten und langfristiges Karrierewachstum.
- Weitere Informationen: Zusammenarbeit mit internationalen Experten in einer wissenschaftlich orientierten Umgebung.
- Warum dieser Job: Übernehme Verantwortung für strategisch wichtige globale Entwicklungsprogramme in einem dynamischen Umfeld.
- Qualifikationen: PhD oder Master in relevanten Bereichen mit umfangreicher Erfahrung in der pharmazeutischen Industrie.
Das prognostizierte Gehalt liegt zwischen 85500 - 104500 € pro Jahr.
Join a globally recognised, innovation-driven pharmaceutical organisation dedicated to advancing breakthrough medicines for patients worldwide.
With a strong research foundation, international reach, and a commitment to scientific excellence, this organisation is at the forefront of developing complex biologic therapies that address significant unmet medical needs.
We are seeking an experienced
Drug Development & CMC Lead (m/f/d) to provide strategic leadership across late-stage drug product development programmes, with a particular focus on biologics and Antibody-Drug Conjugates (ADCs).
This is a high-impact role combining scientific expertise, programme leadership, regulatory strategy, technology transfer, and lifecycle management.
The successful candidate will play a critical role in driving products from late-stage development through commercialisation while collaborating with global stakeholders across development, manufacturing, quality, and regulatory functions.
- Your Responsibilities
- Lead late-stage Drug Product and CMC development activities for innovative biologic and ADC programmes.
- Define and execute formulation, manufacturing, and control strategies to support clinical and commercial objectives.
- Drive technology transfer activities to internal manufacturing sites and external CDMO partners across Europe.
- Provide technical leadership for commercial readiness, process validation, and lifecycle management activities.
- Lead cross-functional development projects, ensuring alignment between R&D, Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams.
- Support and contribute to major regulatory submissions, including BLA, NDA, and post-approval changes.
- Oversee strategic planning, project execution, resource allocation, and risk management within the development portfolio.
- Act as a key stakeholder in global decision‑making processes related to product development and commercialisation.
- Develop and mentor high‑performing scientific teams while fostering a culture of innovation and continuous improvement.
Your Profile
- Ph D in Pharmacy, Pharmaceutical Sciences, Life Sciences, Engineering, or a related field; alternatively, a Master's degree with significant relevant industry experience.
- Extensive pharmaceutical industry experience, ideally 10+ years within Drug Product Development, Pharmaceutical Development, or CMC leadership roles.
- Strong expertise in late‑stage development, commercialisation, and lifecycle management of biologics.
- Direct experience with Antibody‑Drug Conjugates (ADCs) is highly desirable.
- Proven experience supporting or leading BLA, NDA, and other major regulatory submissions.
- Deep understanding of GMP requirements, technology transfer, manufacturing processes, and global CMC development.
- Demonstrated success leading complex, cross‑functional development programmes in international organisations.
- Strong leadership, stakeholder management, communication, and strategic planning skills.
Why Join?
- Lead development activities for cutting‑edge biologic and ADC therapies.
- Take ownership of strategically important global development programmes.
- Work in a highly visible role with significant influence across the organisation.
- Collaborate with international experts in a dynamic, science‑driven environment.
- Benefit from strong professional development opportunities and long‑term career growth.
- Hybrid working model offering flexibility and work‑life balance.
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Drug Development & CMC Lead (m/f/d) Arbeitgeber: Real
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Teamarbeit und persönliche Entwicklung setzt. Unsere Mitarbeiter profitieren von flexiblen Arbeitszeiten, umfangreichen Weiterbildungsmöglichkeiten und einer offenen Unternehmenskultur, die Kreativität und Eigenverantwortung fördert. Zudem liegt unser Standort in einer attraktiven Region, die sowohl eine hohe Lebensqualität als auch zahlreiche Freizeitmöglichkeiten bietet.
