Director, CMC Product Development

Company Description

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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Overview:

Independently manages several clinical development programs of very high complexity utilizing a matrix approach. Leads 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, has 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. Serves as the spokesperson for all CMC functions and ensures information flow among AST and various line functions and stakeholders. Partners with key collaborators, incl. Clinical, Regulatory, Operations, Quality, Preclinical Safety, ADME and Commercial organizations. Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and/or at the Joint Development Committee level driving joint decisions for the development programs. Effective member of governance bodies, including TA Strategic Councils (TASC). Proposes, supports and implements and influences initiatives across Dev Sci and stakeholder functions and realizes management support and endorsement. 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. Drives alignment with functional leadership on complex topics. May supervise or mentor other PDD(s) and develops and implements PM or training tools. S