Director, Bioassay Analytical Development R&D

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 lead 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.
• Support formulation and process development, 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 for traditional antibody formats, multispecific antibodies, fusion proteins, ADCs, AOCs, and other biologics.
• Build 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).
• Support and guide 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).
• Define and set 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.
• Foster 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.
• Provide infrastructure, processes and scientific and quality oversight for cell cultivation, critical reagent management, business and compliance processes in assigned area of responsibility, and interact with external service providers (e.g. transfer or co-validation of test methods).
• Optimize workflows and collaboration with internal and external partners.
• Hold 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.).
• Ensure potency assay and knowledge transfer to commercial organizations.
• Serve as R&D subject matter expert for troubleshooting and investigation of NBE pipeline assets.
• Provide leadership, strategic guidance and talent development for groups of highly skilled analytical scientists, and ensure analytical deliverables are achieved within set timelines, budgets and regulatory frameworks.
• Recruit, promote, and retain top talents via coaching and mentoring and assure effective succession planning.
• Collaborate 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, and Operations.
• Act as scientific mentor for NBE talents.
• Develop long term operating plan for the Bioassay group.
• Manage and develop scientific talent across multiple disciplines and projects to address current and future business needs.
• Identify, evaluate and propose internal and external collaborations to drive scientific innovation and shared learning.
• Be accountable for compliance with Environmental Health and Safety regulations for the group.
• Manage activities within approved external budget.
• Implement technical and scientific concepts with demonstrated impact on multiple projects.
• Know the scientific environment, see relevant trends and propose action to impact the business.
• Provide competent technical and condensed strategic communication to R&D leadership.
• Translate complex technical concepts into clear messages.
• Solve difficult and highly complex technical issues in an evolving regulatory landscape.
• Demonstrate strong oral and written communication, negotiating, influencing and leadership skills.

Qualifications

• Bachelor's Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master's Degree or equivalent education in Science or PharmD or equivalent education with extensive (typically 16 years) of related work; PhD in Science or related field with at least 10 years of relevant pharma/biotech industry experience.
• Strong analytical skills, in-depth knowledge, and hands-on experience in cell culture, including the preparation of frozen cell banks for use in cell-based assays, as well as experience with binding assays such as ELISA and Surface Plasmon Resonance.
• Skilled in designing and qualifying in vitro cell-based assays to reflect the molecule's relevant mode of action.
• Experience in research and/or development environment.
• Strong technical knowledge from early to late stage biopharmaceutical development including manufacturing of biologic products and other parenterals.
• Understands the various scientific disciplines needed in pharmaceutical development of biologics drug product (formulation/analytics, manufacturing process development, scale up/transfer, cGMPs, global regulatory requirements, combination product requirements).
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.
• Demonstrated ability to influence others across areas of scientific disciplines.
• Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation.
• Track record of people management and leading matrix teams, motivating highly skilled technical teams in an environment where compliance with standard procedures is required.