Director Overarching Projects

vor 2 Wochen

Ludwigshafen am Rhein, Deutschland ABBVIE Vollzeit

A career in which you can achieve more? We Offer That.
Looking for challenges where you can grow? We Offer That.
A career where all your skills can come into play? We Offer That.

Welcome to AbbVie As part of an international company with 48,000 employees worldwide and around 3,000 employees in Germany, you will have the opportunity to work closely with us to address the health challenges of tomorrow. Do you have a passion for improving health care around the world and for using your expertise to improve patients' quality of life? In a challenging work environment that allows you to broaden and develop your own skills? You’ve found the right place

Further develop your expertise and join our team as
Director Overarching Projects(all genders)
in Ludwigshafen am Rhein.

The Director Overarching Projects plays a major role to ensure alignment of development activities across all four areas of Biologics-CMC namely Drug Substance, Drug Product, Analytical as well as Device Development across all geographic sites.For the NBE Analytical R&D Department in Development Sciences at AbbVie’s Ludwigshafen site, we are seeking a lab scientist focused on the mass spectrometric characterization of therapeutic proteins (mAbs, ADCs etc.) with high personal responsibility. This is an excellent opportunity for an experienced scientist with a deep understanding of the relevant software and instrumentation to join our motivated and dynamic team.

That means:

- Leads a matrix team of international leaders from all Biologics-CMC sites to ensure seamless collaboration and horizontal alignment of all four areas of Biologics-CMC on all levels
- Develops and aligns overarching development strategies as well as related framework and infrastructure across all four areas of the newly formed Biologics-CMC organization
- Carries global responsibility for development of holistic and efficient Drug Substance/Drug Product Quality Risk Management and seamless connection with Device QRM
- Translates and aligns individual functional platform approaches into holistic default Biologics CMC development strategy that is scalable and customizable to therapeutic area and stage of development
- Global responsibility for development of holistic and efficient Drug Substance/Drug Product/Device Control Strategy approaches for early and late stage clinical and commercial development
- Provides structure and alignment along the development path in all areas - defines deliverables and linkages between areas. Ensures the right discussions are happening at the right time to make the best decisions for projects
- Conceives, manages and drives execution of strategic cross-functional scientific, efficiency as well as culture projects and initiatives across Biologics-CMC
- Ensures compliance with regulatory and environmental requirements. Is always informed of developments in the global technical, regulatory and compliance arena and industry practices.
- Conceives and manages cross-functional process improvement projects with Business Excellence and external partners across all four areas and with external interfaces - e.g. acceleration projects that span all areas of NBE-CMC
- Conceives and initiates projects to drive ONE Biologics-CMC culture

This is how you can make a difference:

- Bachelor’s Degree with at least 12 years of experience in all relevant CMC functions required namely formulation, process development, container closure system development as well as device development; Master’s Degree with at least 10 years of relevant CMC experience required; or PhD with at least 8 years of relevant CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements and resources.
- Excellent communication, leadership and influencing skills, superior team building and team management skills in a matrixed environment
- Proven track record with respect to process improvements/optimizations in a complex multi-site international organization
- Must have a good working knowledge of regulatory requirements including Quality Risk Management and familiarity with relevant research instrumentation and techniques throughout all relevant areas, formulation, analytical, manufacturing process and container closure system development as well as devices.
- Expert knowledge of pharmaceutical sciences and the drug and device development process.
- Must possess superior presentation & scientific writing skills.
- Must have CMC interdisciplinary experience and expertise.
- Creative in implementing entrepreneurial thinking and make smart business decisions. Excels in agility, accountability and motivation
- Ensures superior team performance maintaining high level of morale and culture in the CMC team.

What we offer you:

- a diverse area of work where you can make a real difference
- an open company culture
- attractive remuneration
- intensive onboarding by a mentor
- flexible

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