Associate Director, Biopharmaceutics

About the role

The Molecular Profiling and Drug Delivery (MPDD) function within the Small Molecule CMC organization is accountable for a broad range of deliverables across various stages of drug discovery and development. During lead optimization and through candidate selection, MPDD scientists utilize state-of-the-art automation and computational tools supported by expertise in biopharmaceutics, drug delivery, and solid-state chemistry to collaboratively progress candidates with higher probability of success into development and advise clinical formulation strategy. From candidate selection through clinical proof of concept and product launch, MPDD scientists work in cross-functional teams to identify the commercial solid form of the active pharmaceutical ingredient (API) and establish structure-property-performance correlations to help deliver robust commercial processes and align control strategies across drug substance and product. They also transition drug substance isolation processes and relevant physical characterization methods to commercial manufacturing sites and work within teams to ensure successful regulatory submissions.

Responsibilities

• Develops and achieves disciplined strategy in alignment with functional goals and key scientific objectives within Biopharmaceutics and Drug Delivery, including application to multiple therapeutic modalities - including small molecules, peptides, and genetic medicines at both Discovery and Development stages.
• Leads the application and strategic advancement of PBPK modeling, developing and deploying new in silico tools to strengthen developability assessment, inform decision-making, and support pipeline progression across Discovery and Development stages.
• Demonstrates a strong track record of innovation, introducing new or enhanced capabilities in biopharmaceutics, molecular profiling, and drug delivery through novel research and application of in silico modeling.
• Leverages cross-functional synergies to enable holistic developability characterization in support of pipeline impact.
• Expands scientific influence beyond core discipline by proactively advising and sharing expertise with colleagues and senior management, while identifying and integrating emerging trends into short-term goals to shape cross-disciplinary technology direction.
• Provides expert guidance and review to external scientific collaborations to support advancement of preclinical and early clinical stage assets across AbbVie’s core therapeutic growth areas.
• Leads and collaborates with cross-functional experts including automation scientists, biopharmaceutics scientists, and drug delivery experts to integrate scientific objectives into activities associated with the advancement of Discovery and Development stage pipeline and platforms.
• Safeguards quality and effectiveness of key results of major project plans through robust study designs, early risk assessments, and implementation of innovative fallback strategies.
• Mentors and trains functional colleagues and assesses emerging technological and business challenges relevant to modality-specific drug delivery and automation.
• Presents complex scientific concepts and results spanning biopharmaceutics, automation, and multi-modal drug delivery to scientific and non-scientific leaders, maximizing impact and value of expertise.
• Interacts well with diverse groups across Discovery, ADME, safety, CMC, and clinical teams, maintaining strong working relationships with internal and external collaborators.
• Maintains an internal reputation as a cross-modality expert in Biopharmaceutics, Automation, and Drug Delivery.

Qualifications

• Bachelor's Degree with 16 years of related work; Masters Degree with 14 years of related work; PhD with 8 years of related work experience.
• Extensive experience in biopharmaceutics research in relation to drug absorption across routes of administration including solubility, biorelevant dissolution testing, permeability, ex vivo permeability assessment, and peptide aggregation.
• Knowledge of preclinical and clinical formulation development principles relevant to chemically synthesized molecules across routes of administration.
• Demonstrated strong communication skills and ability to clearly communicate theories and concepts, influence others without authority, and drive technical excellence.
• Excellent self-management skills, organizational skills, and attention to detail.

Additional Information

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. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.