The U.S. Pharmacopeial Convention (USP) Advanced Manufacturing Technologies (AMT) team seeks to define and execute a multi-year strategic roadmap for delivering AI/ML-powered services and solutions to pharmaceutical manufacturers, government agencies, and other funders to increase medicine quality and strengthen supply chain resiliency.
Requirements
- Demonstrated experience applying AI/ML to complex systems as well as developing or applying techniques such as pre-processing, classification, regression, clustering, dimensionality reduction and model selection.
- In-depth experience with digital, data, and analytics techniques in the pharmaceutical industry.
- Working knowledge of advanced pharmaceutical manufacturing technology (e.g., flow chemistry, continuous manufacturing, etc.).
- Knowledge of GMPs and major regulatory agency regulations, specifically as they relate to data science or data validation.
- Preferred degrees in data/computer science or engineering, biological or chemical science or engineering or equivalent discipline with significant emphases on digital, data, and analytics.
- Experience in thinking strategically and executing tactically in equal measure.
- Experience winning and executing on contract work.
Responsibilities
- Define and execute a strategic roadmap for AI/ML services and solutions for USP’s AMT program.
- Lead the execution of detailed, AI/ML aspects of workplans on both client projects and internal development initiatives.
- Develop algorithms and other programs independently.
- Actively be a key opinion leader for AI/ML in pharmaceutical manufacturing in workshops, fora, conferences, white papers, journal articles, and other outlets.
- Provide subject matter expertise on use of AI/ML applications in the work of the AMT program as well as the broader work of the Global Health and Manufacturing Services division.
- Collaborate with the Digital and Information Division and the Science and Standards Division in USP on the role AI/ML plays in the future of pharmaceutical manufacturing, quality paradigms, and supply chain solutions.
- Support AMT’s development roadmap through 2030 by identifying and developing AI/ML models and programs that can be used in continuous manufacturing, additive manufacturing, and spectroscopy-based quality testing and control systems.
Other
- Engage externally to understand the needs and challenges of industry, donors, and government stakeholders as it relates to application of AI/ML in pharmaceutical manufacturing.
- Build and maintain relationships with key partners and clients, focusing on long-term collaborations that drive the effective use of AI/ML in pharmaceutical manufacturing and supply chain solutions.
- In collaboration with the Federal Practice and Business Development teams, develop winning proposals that deliver value to key accounts or offset the costs of USP’s internal projects.
- Strong critical thinking and business acumen.
- Communications skills – both written and oral.
