About this role
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.
Responsibilities:
Serve as spokesperson for CMC on the Asset Development Team, promoting effective information flow and collaboration across all line functionsEnsure 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 inspectionsCritically evaluate and integrate drug substance, product, and device inputs into CMC strategies aligned with business and compliance objectivesUtilize a matrix management approach to oversee a limited project portfolio, negotiating resources and fostering efficiency in timelines, budgets, and team developmentLead contract reviews with third-party partners, manage project budgets with ADT collaboration, and ensure successful CMC execution and quality deliverables within approved fundingGuide CMC development teams by organizing meetings, setting agendas, highlighting achievements and risks, and conducting reviews to efficiently meet phase transition criteriaAdvance 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 experienceStrong educational foundation, with significant experience across CMC functionsExcellent scientific writing and verbal communication skillsExpertise includes regulatory requirements and familiarity with relevant research instrumentation and techniquesSolid knowledge of pharmaceutical sciences and the drug development processInterdisciplinary CMC experience and depth of expertiseNegotiation, influencing, and leadership abilities are well developedCreative and entrepreneurial thinking to guide smart business decisionsFostering a high level of team morale within the CMC group Here's how we can move mountains together
with a diverse work environment where you can have a real impactwith an open corporate culturewith an attractive salarywith an intensive onboarding process with a mentor at your sidewith flexible work models for a healthy work-life balancewith a corporate health management that offers comprehensive health and exercise programswith company social benefitswith a wide range of career opportunities in an international organizationwith top-tier, attractive development opportunitieswith 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.