Director CMC Projects Fulltime

Unternehmensbeschreibung

The job that makes possibilities real in patients' lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to Abb Vie! As part of an international company with 50,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise?

In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Drive your career as Director, CMC Product Development (all genders), where you’ll 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.

• 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 interpolate 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

• Bachelor’s Degree with at least 18 years of CMC experience, a Master’s 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

• 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…