Director, AI/ML Pharmaceutical Manufacturing Innovation

Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a
commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe high-quality medicines
worldwide.
At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.
USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

The USP Advanced Manufacturing Technologies (AMT) team seeks to continuously move medicine manufacturing into the future through practical applications and solutions in advanced manufacturing and analytical technologies that increase medicine quality and strengthen supply chain resiliency. The AMT team helps make drugs in new ways test the quality of drugs in new ways and build more efficient sustainable and competitive industries both in the US and around the globe. To do this work the AMT team brings together expertise in chemistry biologics engineering data science economics business and regulatory science.

The Director for AI/ML Innovation in Pharmaceutical Manufacturing will define and execute a multi-year strategic roadmap for delivering AI/ML-powered services and solutions to pharmaceutical manufacturers government agencies and other funders. While setting the strategy (identifying priorities deeply understanding client needs assessing AI/ML opportunities securing partnerships and funding) you will also delve into hands-on analyses and programming to deliver on both client projects and USP-developed solutions. Example projects include complex pharmaceutical supply chain and risk modeling optimizing manufacturing and analytical testing processes chemometric and retrosynthetic analyses AI-enabled digital twins and independent verification and validation. Throughout the Director ensures that every solution meets our highest standards for reliability accuracy ethical compliance and overall quality as part of USPs AMT program.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Director for AI/ML Innovation in Pharmacutical Manufacturing has the following responsibilities:

• Develop and execute a strategic roadmap for AI/ML services and solutions for USPs AMT program.
• 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 USPs internal projects.
• Lead the execution of detailed AI/ML aspects of workplans on both client projects and internal development initiatives. This can include both overseeing project work and/or developing 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.
• Generate valuable insights into the technical financial and regulatory return on investment for leveraging AI/ML in pharmaceutical manufacturing processes.
• Support AMTs 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 duties and projects assigned.

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

• Bachelors degree and twelve (12) years of related experience; masters degree and seven (7) years of related experience; or Ph.D. (or equivalent advanced degree) and three (3) years of related experience.
• In-depth experience with digital data and analytics techniques in the pharmaceutical industry.
• 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.
• Strong critical thinking and business acumen.
• Communications skills both written and oral.
• Demonstrates initiative to solve problems; effective at making and implementing decisions.
• Desire to affect change and drive public health impact.
• Willingness to travel up to 10% as needed.

Additional Desired Preferences

• 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.
• MBA or equivalent a plus.
• Experience in thinking strategically and executing tactically in equal measure.
• Knowledge of GMPs and major regulatory agency regulations specifically as they relate to data science or data validation.
• Working knowledge of advanced pharmaceutical manufacturing technology (e.g. flow chemistry continuous manufacturing etc.).
• Experience winning and executing on contract work.

Supervisory Responsibilities

None this is an individual contributor role.

Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial well-being is protected.
Compensation
Base Salary Range: USD $160700.00 $213700.00annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other job-related reasons.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Director