Purpose:

For the Biologics Analytical R&D department at the AbbVie site in North Chicago, we are looking for an experienced leader to guide a diverse team of scientists supporting AbbVie's pipeline of monoclonal antibodies (mAbs), multispecific antibodies, Antibody Drug Conjugates (ADCs), Antibody Oligonucleotide Conjugates (AOCs), tLNPs, Peptides and other biologics. The team develops state-of-the-art, innovative potency assays, including cell-based and binding assays, using the latest technology standards, and drives industry-leading analytical methods and control strategies that advance programs through clinical development.

Responsibilities

• Build and leads a newly formed team of up to 10 dedicated scientists and people leaders, with recruitment and hiring required to staff the team, in charge of potency and molecule characterization assay development for single and combined biological mode of actions (MoA) as single point of contact and center of excellence in Development Sciences. This includes formulation and process development support, QC-ability assessment of discovery assays, improvement or development of alternative and new assay formats, assay validation, routine testing and tech transfers for early, mid and late-stage development programs e.g. for traditional antibody formats, multispecific antibodies, fusion proteins, ADCs, AOCs, and other biologics, directed against neurological, immunological and oncological diseases, as well as novel complex therapeutic areas such as gene therapies.
• Builds a strong scientific interface to structural characterization units globally and locally to support assessment and elucidation of molecule liabilities and critical quality attributes related to binding and biological activity (structure-function relationship). Supports and guides adjacent organizations with scientific expertise on novel binding and biological activity formats for internal and external programs as global center of excellence (e. g. due diligences, partnered programs).
• Defines and sets the framework for a global development strategy of potency assays for traditional and novel therapeutic areas: assay format of cell-based and binding assays, potency assay implementation, validation and method comparability strategy in a GMP and scientific environment.
• Fosters innovation and implementation of new technologies and platformability assessments in the field of traditional and novel formats such as automation and robotics to streamline development routine testing and cell banking, for early and mid-stage development programs.
• Provides infrastructure, processes and scientific and quality oversight for cell cultivation, critical reagent management, business and compliance processes in assigned area of responsibility, interacts with external service providers (e. g. transfer or co-validation of test methods). Optimizes workflows and collaboration with internal and external partners.
• Holds a strong relationship to program management in the respective area of expertise being accountable for tracking and providing potency assay development deliverables to project teams in time, and supporting generation of early and mid-stage submissions for all NBE Analytical A&D programs (e.g. IND/CTD/Briefing Books etc.). Ensures potency assay and knowledge transfer to commercial organizations. Also serves as R&D subject matter expert for troubleshooting and investigation of NBE pipeline assets.
• Provides leadership, strategic guidance and talent development for groups of highly skilled analytical scientists, and ensures analytical deliverables are achieved within set timelines, budgets and regulatory frameworks.
• Recruit, promote, and retain top talents via coaching and mentoring and assures effective succession planning.
• Collaborates with stakeholders and partner organizations, such as:

• Discovery for technical transfer or development of MoA assay formats
• Analytical Leads across sites
• NBE tech centers (AIMS/Characterization Teams)
• NBE project teams
• Outsourcing
• Analytical Strategy and Operations
• Operations

Additional responsibilities:

• Acts as scientific mentor for NBE talents
• Develops long term operating plan for the Bioassay group
• Manages and develops scientific talent across multiple disciplines and projects to address current and future business needs
• Identifies, evaluates and proposes internal and external collaborations to drive scientific innovation and shared learning
• Accountable for compliance with Environmental Health and Safety regulations for the group
• Manages activities within approved external budget
• Implements technical and scientific concepts with demonstrated impact multiple projects. Knows scientific environment sees relevant trends and proposes action to impact the business
• Competent technical and condensed strategic communication to R&D leadership. Ability to translate complex technical concepts into clear messages
• Solves difficult and highly complex technical issues in an evolving regulatory landscape
• Strong oral and written communication, negotiating, influencing and leadership skills