AbbVie
Associate Director/Director CMC Product Development(m/w/x)
Vollzeit
Keine Angabe
Ludwigshafen am Rhein
AB
AbbVie1 Monat
Director, CMC Product Development(m/w/x)
Vollzeit
Senior
Keine Angabe
Ludwigshafen am Rhein
Nejo KI-Zusammenfassung
In this role, you will lead the CMC aspects of drug development, ensuring compliance and quality while guiding a global team. Your daily responsibilities will include strategic alignment, resource negotiation, and fostering collaboration across functions.
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Anforderungen
- •Bachelor’s Degree with at least 18 years of CMC experience, Master’s Degree with at least 16 years of relevant CMC experience, or PhD with at least 10 years of relevant CMC experience
- •Strong educational foundation with significant experience across CMC functions
- •Excellent scientific writing and verbal communication skills
- •Expertise in regulatory requirements and familiarity with relevant research instrumentation and techniques
- •Solid knowledge of pharmaceutical sciences and the drug development process
- •Interdisciplinary CMC experience and depth of expertise
- •Negotiation, influencing, and leadership abilities
- •Creative and entrepreneurial thinking to guide smart business decisions
- •Fostering a high level of team morale within the CMC group
Bachelor-Abschluss
ODER
Master-Abschluss
ODER
Doktor / Ph.D.
ODER
Pflichtschulabschluss
Berufserfahrung
10–18 Jahre
Deine Aufgaben
- •Oversee CMC aspects of drug and combination product development
- •Align strategy with clinical and regulatory goals
- •Serve as spokesperson for CMC on the Asset Development Team
- •Promote effective information flow and collaboration across functions
- •Ensure compliance with global regulatory and quality standards
- •Participate in meetings with authorities and pre-approval inspections
- •Evaluate and integrate drug substance, product, and device inputs into CMC strategies
- •Utilize a matrix management approach to oversee project portfolio
- •Negotiate resources and foster efficiency in timelines and budgets
- •Lead contract reviews with third-party partners
- •Manage project budgets in collaboration with ADT
- •Ensure successful CMC execution and quality deliverables
- •Organize meetings for CMC development teams and set agendas
- •Highlight achievements and risks during reviews
- •Advance corporate and divisional initiatives
- •Encourage creative and scientific thinking
- •Champion quality and resource management
- •Develop, update, and implement CMC product development plans
- •Ensure regulatory, health, safety, and environmental compliance
- •Support high-quality global filings, approvals, and product launches
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Abwechslungsreiche Aufgaben
- •Diverse work environment
Lockere Unternehmenskultur
- •Open corporate culture
Mentoring & Coaching
- •Intensive onboarding process
Flexibles Arbeiten
- •Flexible work models
Gesundheits- & Fitnessangebote
- •Corporate health management
- •Comprehensive health programs
Mitarbeiterrabatte
- •Company social benefits
Karriere- und Weiterentwicklung
- •Wide range of career opportunities
- •Attractive development opportunities
- •Strong international network
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AbbVie erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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