More than a job. It's a chance to make a real difference.
At AbbVie, we strive to push the boundaries of science and innovation to improve life quality globally. As part of our vibrant team, you'll help transform the possibilities in neurological and psychiatric care into realities. 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). In the role of PPDST co-chair for Asset Strategy Teams (ASTs) and key member of AST, you have accountability for creating a CMC strategy and development plan that aligns with overarching asset strategy to effectively advance to next key milestone and to deliver a differentiated product. You serve as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders. You will also partner with key collaborators, incl. Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations. 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.
Make your mark by:
- 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. Participating in meetings with Regulatory Authorities, responds to regulatory queries, and participates in communications and meetings with regulatory agencies. Taking accountability for creating CMC development plan incl. timelines, risks and mitigations in collaboration with line functions and AST
- 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. Conducting periodic reviews to ensure that phase transition criteria are met in the most efficient and resource effective manner. Asseting modalities may include new chemical entities (NCEs), new biological entities (NBEs), antibody-drug-conjugates (ADCs), toxins, and gene and cell therapies
- Reviewing contracts with Third Party Manufacturers and consultants. Developing budget needs in collaboration with AST, obtaining resources from functional areas and staying within the approved funding. Driving legal and financial aspects of outsourcing, contracts, and statements of work (SOW). Demonstrating excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders. Demonstrating strong negotiating, influencing, and leadership skills.
- Leading teams and partner interactions for new due diligence in-licensing opportunities and successfully transitioning leadership for programs where development is internalized.
- 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. Implementing creative approaches to conserve resources, and achieve efficiency with respect to time, and budget. Providing feedback and input to functional managers and identifies growth needs for team members.
- Ensuring strategic alignment with other key Development Sciences functions, esp. Preclinical Toxicology/Biological Sciences and Quantitative, Translational and Analytical Sciences (QTAS)/ADME (adsorption, distribution, metabolism and excretion) to ensure key deliverables for asset advancement are met and risks and mitigation plans are in place. 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
- Promoting scientific and entrepreneurial thinking, encourages creativity and manages quality and results with respect to science, time, budget and resources.
- 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.