Director CMC Projects (all genders) Fulltime, permanent

Drive your career as Director CMC Product Development (all genders) where youll oversee the CMC aspects of drug and combination product development across programs align strategy with clinical and regulatory goals and lead a global cross-functional team. Collaborate with key partners communicate critical updates to senior management and drive robust CMC plans in support of global filings and approvals. Ideal candidates bring deep CMC drug development and team leadership experience strategic vision and a strong record in supporting clinical and regulatory milestones.

Join us to shape the future of global drug development.

Responsibilities:

• Serve as spokesperson for CMC on the Asset Development Team promoting effective information flow and collaboration across all line functions
• Ensure excellence in science technology and deliverables while maintaining compliance with global regulatory and quality standards including active participation in meetings with authorities and pre-approval inspections
• Critically evaluate and integrate drug substance product and device inputs into CMC strategies aligned with business and compliance objectives
• Utilize a matrix management approach to oversee a limited project portfolio negotiating resources and fostering efficiency in timelines budgets and team development
• Lead contract reviews with third-party partners manage project budgets with ADT collaboration and ensure successful CMC execution and quality deliverables within approved funding
• Guide CMC development teams by organizing meetings setting agendas highlighting achievements and risks and conducting reviews to efficiently meet phase transition criteria
• Advance corporate and divisional initiatives encourage creative and scientific thinking and champion quality and resource management.
• Develop update and implement CMC product development plans while ensuring regulatory health safety and environmental compliance and support high-quality global filings approvals and product launches

Qualifications :

• Bachelors Degree with at least 18 years of CMC experience a Masters Degree with at least 16 years of relevant CMC experience or a 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 includes 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 are well developed
• Creative and entrepreneurial thinking to guide smart business decisions
• Fostering a high level of team morale within the CMC group

Zusätzliche Informationen :

Heres how we can move mountains together

• with a diverse work environment where you can have a real impact
• with an open corporate culture
• with an attractive salary
• with an intensive onboarding process with a mentor at your side
• with flexible work models for a healthy work-life balance
• with a corporate health management that offers comprehensive health and exercise programs
• with company social benefits
• with a wide range of career opportunities in an international organization
• with top-tier attractive development opportunities
• with a strong international network

Multiple times we have been globally recognized as a Great Place to Work and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality equity diversity and inclusion (EED&I) a commitment that is fundamental to us. This includes appreciating different perspectives creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie your individual contributions count help us move mountains together. Be a part of our success grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you We look forward to receiving your application! All you need is a complete CV we will discuss everything else with you in person.

AbbVie setzt sich für Chancengleichheit ein und verpflichtet sich mit Integrität zu arbeiten Innovationen voranzutreiben Leben zu verändern und unserer Gemeinschaft zu dienen. Chancengleichheit bei Arbeitgeber/Veteranen/Behinderten.

Remote Work :

No

Employment Type :

Full-time