BioSpace
Director, AI/ML Pharmaceutical Manufacturing Innovation
BioSpace, Rockville, Maryland, us, 20849
Director, AI/ML Pharmaceutical Manufacturing Innovation
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 brings together expertise in chemistry, biologics, engineering, data science, economics, business, and regulatory science.
Role overview 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 (priorities, deeply understanding client needs, assessing AI/ML opportunities, securing partnerships and funding), you will also engage in 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 USP's AMT program.
Impact 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, USP's 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.
Responsibilities
Develop and execute a strategic roadmap for AI/ML services and solutions for USP's 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 USP's internal projects.
Lead the execution of detailed AI/ML aspects of workplans on both client projects and internal development initiatives. This can include 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 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 duties and projects assigned.
Qualifications
Bachelor's degree and twelve (12) years of related experience; master's 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 and developing or applying techniques such as pre-processing, classification, regression, clustering, dimensionality reduction and model selection.
Strong critical thinking and business acumen.
Excellent written and oral communications skills.
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 Preferences
Preferred degrees in data/computer science or engineering, biological or chemical science or engineering or equivalent discipline with significant emphasis on digital, data, and analytics.
MBA or equivalent is a plus.
Experience 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 contract work.
Position Details Supervisory Responsibilities: None, this is an individual contributor role.
Benefits: USP provides 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 160,700 - 213,700 annually. Target Annual Bonus: Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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.
#J-18808-Ljbffr
Role overview 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 (priorities, deeply understanding client needs, assessing AI/ML opportunities, securing partnerships and funding), you will also engage in 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 USP's AMT program.
Impact 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, USP's 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.
Responsibilities
Develop and execute a strategic roadmap for AI/ML services and solutions for USP's 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 USP's internal projects.
Lead the execution of detailed AI/ML aspects of workplans on both client projects and internal development initiatives. This can include 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 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 duties and projects assigned.
Qualifications
Bachelor's degree and twelve (12) years of related experience; master's 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 and developing or applying techniques such as pre-processing, classification, regression, clustering, dimensionality reduction and model selection.
Strong critical thinking and business acumen.
Excellent written and oral communications skills.
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 Preferences
Preferred degrees in data/computer science or engineering, biological or chemical science or engineering or equivalent discipline with significant emphasis on digital, data, and analytics.
MBA or equivalent is a plus.
Experience 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 contract work.
Position Details Supervisory Responsibilities: None, this is an individual contributor role.
Benefits: USP provides 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 160,700 - 213,700 annually. Target Annual Bonus: Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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.
#J-18808-Ljbffr