AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Join a global powerhouse with over 50,000 employees worldwide, including 3,000 in Germany, where your expertise will address tomorrow's unmet medical needs.
As an Associate Director/Director CMC Product Development you independently manage programs of various complexity utilizing a matrix approach. You lead Chemistry, Manufacturing and Controls (CMC) teams and Product Presentation and Device Strategy Teams (PPDST) of functional representatives from various departments and divisions for projects involving external collaboration partners per Pipeline Commercialization Model (PCM). Apprises CMC and Stakeholder Management of strategies, plans and risks through regular communications and periodic reviews throughout development and in support of global filings and approvals. In addition you support and implement CMC functional initiatives and across-asset strategies.
Representing all CMC areas on the AST serving as spokesperson for the CMC project team and ensuring information flow among the AST and all line functions. Ensuring high quality science, technology, deliverables, and certifies compliance with global regulatory and quality requirements. Leading PPDST and/or CMC development teams for assigned projects: scheduling meetings, developing agendas, issuing highlights, identifying risks and develops mitigation plans with technical functions. Driving legal and financial aspects of outsourcing, contracts, and statements of work (SOW). Managing a limited number of projects of various complexity utilizing matrix management approach. Negotiating for additional resources when required, influences project timelines to ensure proper completion of required activities. Integrating and implementing pre-clinical development plans and updates as necessary in collaboration with the global development teams and respective line functions.
Supporting and implements CMC functional initiatives and across-asset strategies
Ensuring compliance with regulatory, health, safety and environmental requirements. Staying abreast of developments in global technical, regulatory and compliance arena and industry practice.
Apprising management of plans and risks through regular communications, periodic reviews, in support of global filings, approvals and general agency feedback. Responsible for the quality and effectiveness of dossiers and communication with health authorities at global level.
Bachelor’s Degree with at least 10 years of experience in a variety of relevant functions required; or PhD with at least 6 years of relevant experience required. with a diverse work environment where you can have a real impact
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. Sounds like the perfect career opportunity for you?