AbbVie Director of Bioassay Analytical Development R&D leading a team developing potency assays for biologics at AbbVie. Drives assay development, validation, and global strategy for multiple therapeutic areas.
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)
Qualification
Strong analytical skills
Required
Bachelor’s Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master’s Degree or equivalent education 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 incl. 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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
