Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview We are seeking a highly motivated and experienced Team Lead Data Engineer to join our dynamic team. This role demands a strong technical foundation in AWS data services, coupled with exceptional communication and collaboration skills, and experience in integrating data for use in Microsoft Power BI. You will be responsible for designing, building, and maintaining scalable data pipelines and infrastructure on AWS, while also acting as a key liaison between technical teams and end-users, and ensuring data is readily available and optimized for Power BI reporting and analytics. Your ability to translate complex technical concepts into clear, actionable insights for non-technical stakeholders is crucial. 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 Team Lead Data Engineer has the following responsibilities: Design, develop, and implement robust data pipelines and data warehousing solutions using AWS services (e.g., Redshift, Glue, S3, Lambda, EMR, Kinesis). Optimize data storage, retrieval, and processing for performance and scalability. Manage and maintain AWS data infrastructure, ensuring high availability and reliability. Develop and maintain ETL/ELT processes to ingest, transform, and load data from diverse sources, with a focus on preparing data for Power BI consumption. Implement data quality checks and monitoring to ensure data accuracy and consistency. Automate data pipeline processes for efficiency and reliability. Act as a primary point of contact for data-related inquiries from business users and stakeholders, including those using Power BI. Gather and analyze user requirements, translating them into technical specifications, and also understand the requirements of data needed for effective Power BI dashboards. Clearly communicate technical concepts and solutions to non-technical audiences. Collaborate with data scientists, analysts, and other teams to support data-driven initiatives. Create and maintain documentation for data pipelines and data infrastructure, geared toward both technical and non technical audiences, and also include documentation on how data is structured for Power BI. Design and implement data models that support analytical and operational needs, and also optimize data models for Power BI performance. Contribute to the development of data architecture and best practices. Implement and maintain data security measures within the AWS environment. Ensure compliance with data governance policies and regulations. Troubleshoot and resolve complex data related issues. Ensure data pipelines deliver data in a format suitable for Power BI analysis. Work with Power BI developers to understand data requirements and optimize data structures for reporting. Troubleshoot data issues related to Power BI dashboards and reports. 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: Bachelor's or Master's degree in Computer Science, Engineering, or a related field. Minimum 5+ years of proven experience in data engineering, with a strong focus on AWS services. Proven expertise in AWS data services (Redshift, Glue, S3, Lambda, EMR, Kinesis, etc.). Strong proficiency in SQL and Python. Experience integrating data with Microsoft Power BI. Excellent communication and presentation skills, with the ability to explain complex technical concepts to non-technical audiences. Experience in gathering and documenting user requirements. Strong problem-solving and analytical skills. Ability to work effectively in a collaborative environment. Experience in creating easily understood documentation. Experience with data modeling and data warehousing concepts. Additional Desired Preferences AWS certifications (e.g., AWS Certified Data Analytics - Specialty). Experience with other data visualization tools. Experience with Power BI dataflows. Experience with DevOps practices and tools. Aptitude for identifying problems quickly and developing effective solutions. Ability to manage expectations and build relationships with various stakeholders. Ability to navigate and resolve conflicts within the team and with stakeholders. Supervisory Responsibilities Yes, one senior software engineer. 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 $131,500.00 $170,500.00 annually. 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. 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. Job Category Information Technology Job Type Full-Time
Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview The Senior International Regulatory Intelligence Manager will lead the development and execution of an international regulatory intelligence program that will inform enterprise decision-making; support regulatory interactions on policy issues; and identify opportunities or risks that may impact USPs mission. While this role is an individual contributor, this professional but will be responsible for leading a collaborative effort across USPs organization to build and engage staff and leadership in a program that supports USPs current work and inform future strategy. Deliverables include frequent written analysis, and the effective use of current digital and technology tools to identify relevant regulatory trends. This position will also address specific policy and regulatory research needs and provide pertinent insights and analysis towards identifying opportunities to improve medicine quality. How will YOU create impact here at USP? In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The Senior Manager, International Regulatory Intelligence has the following responsibilities: Formalize, manage and execute an international regulatory intelligence program to undertake research and inform the organization of critical policy and regulatory developments relevant to USPs mission. Effectively lead a cross-functional team or working group of internal USP experts in the execution of this process. Identify meaningful opportunities for USP to comment on international regulatory policy dockets aligned with our mission and priorities, and coordinate regional and other colleagues in the development of such comments. Provide analysis and insights that deepen USPs understanding of international regulatory environments for medicines as well as relevant quality paradigm shifts relevant to USPs work. Manage commissioned or outsourced work, as needed, to support the regulatory intelligence portfolio. Specific focus is on collecting and synthesizing international perspectives on existing and evolving regulatory policy positions related to USPs mission. This involves an understanding of the diversity of healthcare systems across the globe, as well as the interplay between US and ex-US policy. This role will collaborate closely with the US Regulatory Intelligence team. Collaborating with public policy and regulatory affairs colleagues located globally, identify key trends that will inform USPs policy priorities and conduct analysis of opportunities and risks. Play an active role in supporting the execution of key projects within the International Government & Regulatory Affairs Team and broader Global External Affairs Team. Outputs and deliverables will include frequent internally published analysis of key international regulatory trends and implications for USP. 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 required in relevant field (Life Sciences, Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, etc.). Eight (8) years of experience working in regulatory intelligence, regulatory affairs, public policy, or public health that includes experience working with international teams. Prior experience working for a science-based organization related to public health or pharmaceuticals. Examples include NGOs, government, non-profit organization, or industry/private sector organizations. Experience with perspectives across sectors / disciplines in healthcare ecosystems is preferred. Experience utilizing and pro-active embracement of digital and technology tools to identify regulatory trends in key countries. Experience with and knowledge of regulatory policy making processes and analysis, including researching writing policy briefs, policy positions and other tools. Experience developing statements for the record, formal comment letters, and evidence-based policy position statements. Excellent communication, presentation, and interpersonal skills, as well as experience communicating across cultures. Strong analytical and writing skills, with the ability to synthesize and report complex information, and to develop applicable strategies to align with expected outcomes. Project management and organizational skills, as well as ability to adapt to internal and external changes. Additional Desired Preferences Advanced degree (Life Sciences, Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, etc.) or other related field preferred. Experience working in a matrixed organization. Expertise in conducting literature searches and evidence-based reviews, soliciting expert opinion through various methods, and writing/editing sound scientific reports on a wide variety of topics and issues related to public health and public policy. Ability to influence and drive cross-functional initiatives without direct authority. 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 $121,000.00 Mid.$153,500.00 annually. 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. 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. Job Category Ext. Affairs, Regulatory, & Communications Job Type Full-Time
Description 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 1,300 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 Senior Director, Digital Engagement oversees all digital media channels and content at USP. This leader will enhance digital engagement, strengthen our digital platforms and channels, and expand our ability to engage audiences within and outside the U.S. They will lead a team of functional experts in enterprise digital campaigns and multi-channel governance, developing strategies to drive innovation and improve stakeholder engagement. Key responsibilities include optimizing social media, website, and email platforms; managing digital analytics; and aligning initiatives with USPs strategic goals. The ideal candidate is a strategic thinker with a deep understanding of digital marketing, social media, and analytics, with a proven record in driving successful digital initiatives across a global organization. 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 Senior Director, Digital Engagement has the following responsibilities: Responsible for developing a comprehensive, forward-thinking global digital engagement strategy that enhances USPs digital platforms and channels to optimize reach, engagement, and impact on organizational goals. Sets paid and organic social media strategies, ensuring integration with overall policy advocacy, science communications priorities, marketing strategies and campaigns. Oversees email marketing campaigns for major enterprise initiatives, from strategic planning to execution and performance analysis. Responsible for continual content and technology improvement of USPs website. Collaborates with Web Experience Lead to evolve websites role in facilitating the user journey. Uses data-driven insights and performance analytics to inform decision-making and optimize digital strategies. Analyzes key metrics across web, social media, email, and other digital platforms to assess effectiveness, identify trends, and refine strategies. Oversees digital technology stack (platforms), ensuring it meets the organization's needs and is up to date with the latest advancements. Collaborates with key internal marketing and engagement to ensure cohesive and effective digital media planning and global execution. Responsible for financial management tied to digital engagement, ensuring resources are allocated efficiently and align with strategic priorities. Includes budget planning, forecasting, and financial performance analysis to support digital initiatives and maximize return on investment (ROI). Drives digital and social media transformation within the organization by developing and leading workshops and educational programs to enhance digital acumen across all departments. Fosters a culture of continuous learning and innovation in digital marketing practices. 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 in communications, marketing, or relevant field. 10 years of experience in a digital engagement or related role will be considered in lieu of a degree. Minimum of 10 years of experience in digital engagement, marketing, advocacy, transformation, or related digital roles; at least 4 years in a leadership position. Proven record of developing and executing digital transformation initiatives and driving measurable results. Experience in digital marketing, with a strong emphasis on social media strategy and execution. Knowledge of website strategy, email marketing, analytics, and integrated digital campaigns. Strong understanding of digital technology stacks and governance. Understanding of AI technology, use cases and ethics. Experience with digital advocacy focused on policymaker and stakeholder engagement. Excellent team leadership, project management, communication, and collaboration skills. Strong analytical and problem-solving skills. Experience working globally and within a global, matrixed organization. Minimum of five (5) years of people management experience. Responsible for leading, developing, and mentoring a high-performing digital engagement team; fostering a culture of innovation, collaboration, and continuous learning; and providing guidance on best practices, goal-setting, and professional growth opportunities for team members. Additional Desired Preferences Advertising, Digital Marketing, Public Relations, or Public Affairs agency experience. Regulatory affairs, public health, or pharmaceutical industry knowledge. Strategic with strong problem solving and critical thinking skills. Ability to work with and influence a wide range of cross-functional teams and leaders within a matrixed organization. Supervisory Responsibilities Yes, people management responsibilities include: Social Media Senior Manager. Social Media (Senior) Manager. Senior Manager, Web Experience (manages Senior Web Content Specialist). 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 $198,000.00 - $257,000.00 annually. 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. 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. Job Category Ext. Affairs, Regulatory, & Communications Job Type Full-Time
Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview The Case Management Program Manager at the United States Pharmacopeia (USP) is responsible for managing the monograph production planning process, ensuring the efficient tracking, monitoring, and reporting of monograph production progress against established plans. This role involves coordinating cross-functional teams, implementing process improvements, and ensuring timely execution of monograph development in alignment with USPs strategic objectives. The Program Manager will develop robust case management workflows to track issues, mitigate risks, and support continuous improvement efforts. How will YOU create impact here at USP? In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The Case Management Program Manager has the following responsibilities: Monograph Production Planning & Execution: o Develop and maintain the monograph production plan, ensuring alignment with USPs priorities, Program Unit Teams needs, & Publication schedules. o Collaborate with Program Unit Teams, Publication Team, Finance, and Executive stakeholders to establish realistic production plan, production timelines, and resource allocation for monograph development. o Identify and escalate potential bottlenecks or challenges in monograph production to ensure timely resolution. Tracking, Monitoring & Reporting: o Establish and oversee processes for tracking and monitoring monograph production against the approved plan. o Generate regular reports and dashboards to provide leadership with visibility into monograph development progress, challenges, and trends. o Develop performance metrics and key indicators to assess the efficiency of the monograph development pipeline. Case Management & Issue Resolution: o Collaborate with Software Development Team to rapidly resolve case issues escalated by Program Unit Teams that impact adhere to production plan. o Support the effective prioritization of enhancement requests for Case Management System o Drive/Support Case Management System enhancement to improve efficiency and quality of monograph production. Stakeholder Engagement & Process Improvement: o Act as the primary liaison between Program Unit Teams, Publication Team, Finance, and Executive stakeholders to ensure transparency in monograph production. o Identify opportunities for process improvement and recommend strategies to enhance efficiency, quality, and effectiveness in monograph development o Support training efforts and develop resources to enhance stakeholder understanding of monograph planning and case management processes. 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: Education: Bachelors degree required, preferably in life sciences, public health, or a related field. Experience: Minimum of 5-7 years of experience in program management, scientific operations, or manufacturing operations. Proven experience applying Lean methodologies (e.g., tiered accountability, value stream mapping, problem-solving frameworks) in a scientific / transactional setting. Strong track record of developing and executing production plans, tracking performance metrics, and driving process improvements. Skills & Competencies: Strong project management skills, including experience with production planning, issue tracking, and process improvement. Expertise in Lean tools and principles (e.g., A3 problem-solving, 5 Whys, Kaizen, PDCA cycles). Excellent analytical and data interpretation skills to track performance and recommend improvements. Strong interpersonal and communication skills to engage cross-functional teams and external stakeholders. Proficiency in project tracking software. Proficiency in case management system is preferred. Ability to manage multiple priorities in a fast-paced, mission-driven environment. Additional Desired Preferences Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration. Supervisory Responsibilities No, 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 $83,500.00 - $106,250.00 annually. 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. 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. Job Category Project Management Job Type Full-Time
Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview We are seeking a highly skilled and motivated Senior Software Development Manager to lead a dynamic team of engineers responsible for developing and maintaining critical software applications. The ideal candidate will possess a strong technical background, exceptional leadership abilities, and a proven track record of successfully delivering complex projects. This role requires a seasoned manager who can effectively balance technical expertise with team management, strategic planning, and stakeholder communication at a senior level. The Senior Software Development Manager will play a key role in shaping the technical direction of the team and contributing to the overall success of the organization. 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 Senior Software Development Manager has the following responsibilities: Collaborate closely with product managers, business analysts, and other stakeholders, including senior executives, to understand business requirements and translate them into strategic technical plans. Communicate effectively with stakeholders at all levels, providing regular updates on project status, risks, and dependencies, with a focus on aligning technical solutions with business strategy. Build strong relationships with stakeholders, manage expectations, and ensure alignment between technical solutions and business goals, influencing decision-making and driving consensus. Contribute to the development of the department's strategic plan, aligning software development initiatives with business objectives. Identify opportunities to improve software development processes, tools, and technologies. Evaluate new technologies and make recommendations for their adoption. Provide technical guidance and expertise to the development team, ensuring adherence to best practices, coding standards, and architectural principles. Participate in architectural design and code reviews to ensure scalability, maintainability, performance, and security of software solutions, driving innovation and technical excellence. Drive innovation and encourage the team to explore new technologies and approaches, fostering a culture of continuous learning and experimentation. Troubleshoot complex technical issues and provide solutions as needed, serving as a technical escalation point for the team. Utilize agile methodologies (e.g., Scrum, Kanban) to manage development sprints and ensure iterative progress, driving continuous improvement in agile processes. Manage project scope, identify and mitigate risks, and ensure projects are delivered on time, within budget, and to the required quality standards, providing proactive communication and problem-solving. The ability to quickly learn and adapt to new technologies is essential. An interest in staying hands-on technical as well as wearing that team management hat. 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: Bachelor's degree in Computer Science, Information Systems, or a related field. Minimum of 8 years of experience in software development, with a strong understanding of software development principles and practices. Minimum of 5 years of experience in a leadership or management role, leading software development teams. Proven experience managing the full software development lifecycle for complex, enterprise level projects. Strong technical skills in relevant technologies, including but not limited to: JavaScript, TypeScript, and Java. Excellent leadership, communication, and interpersonal skills, with the ability to influence and inspire others. Strong problem-solving and decision-making abilities, with a focus on strategic thinking and risk management. Ability to work effectively in a fast-paced, dynamic environment, with a high degree of adaptability and resilience. Experience with agile development methodologies (e.g., Scrum, Kanban) at scale. Demonstrated ability to manage multiple complex projects simultaneously, with a focus on delivering results. Strong stakeholder management skills, with a proven ability to build and maintain relationships with business partners, including senior executives. Excellent team building skills, with a track record of motivating and developing high-performing teams, including mentoring and coaching senior team members. Experience with budget management and resource allocation. Additional Desired Preferences Clear and concise communication is crucial for conveying technical information to both technical and non-technical stakeholders. Ability to lead and motivate teams, manage projects, and drive successful application implementations. Aptitude for identifying problems quickly and developing effective solutions. Ability to manage expectations and build relationships with various stakeholders. Ability to navigate and resolve conflicts within the team and with stakeholders. Experience with cloud technologies (e.g., AWS, Azure). Experience with DevOps practices and tools. Supervisory Responsibilities Yes, 6 direct reports: 1 Software Engineer 1 Staff Software Engineer 4 Senior Software Engineers 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 $131,500.00 $170,500.00 annually. 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. 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. Job Category Information Technology Job Type Full-Time
Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview This is a hands-on, non-supervisory position in Reference Standards Production (RSP). This position works collaboratively across departments in Global Labs and Technical Operations (GLTO) to lead the successful implementation of new operational strategies required develop physical materials. The incumbent is responsible for coordinating cross-functional teams, managing resources, mitigating risks, and ensuring projects are completed on time and within budget. The Operations Project Manager monitors activities across established producers of USP physical materials to ensure program deliverables and quality requirements are met. How will YOU create impact here at USP? In this role at USP, you contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The Operations Project Manager has the following responsibilities: Lead cross-functional teams to establish new manufacturing and production models required for development (e.g. outsourced production) of USP physical materials. Monitor project progress against established timelines and adjust as needed to ensure timely completion. Coordinate internal and external resources to ensure that projects adhere to scope, schedule, and budget. Work closely with Material Operations Director in analyzing existing operational workflows and identifying areas for improvement. Support implementation of production improvement efforts to ensure that processes used to develop physical materials result in the timely production of high-quality products. Monitor production activities across established manufacturers of USP physical materials to ensure production deliverables, timelines, and quality requirements are met. Develop tools and processes for managing day-to-day project activities, assessing risks, tracking progress and reporting outcomes. Effectively communicate project updates, risks, and key decisions to stakeholders at all levels. Support process development and documentation in Standard Operating Procedures (SOP). Collect and analyze data to measure process performance, identify trends, and inform decision making. Track key performance indicators (KPI) to measure the effectiveness of implemented processes and deployed resources. Perform other duties as required. 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: B.S. in science or project management related field. Minimum of 5 years of relevant experience in project management or operations management roles with demonstrated proficiency leading complex projects and teams independently. Equivalent combination of education and experience may be substituted. Proven experience in managing complex projects from initiation to completion in the field of manufacturing/production, product development, or related field. Strong project management skills. Excellent communication and collaboration skills. Additional Desired Preferences Experience in operations and manufacturing preferred. Superior interpersonal skills: professionalism, accountability, team building, and conflict resolution. PMP certification is a plus. Strong documentation and presentation skills. Results driven with demonstrated successful outcomes. Ability to handle multiple concurrent projects or tasks. Proficiency in MS Office programs. Strong critical thinking and problem-solving skills. Understanding of ISO 9001, 17025, 17034 guidelines and quality systems. Proficiency in data analysis tools and methodologies. 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 $83,500.00 $106,250.00 annually. 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. 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. Job Category Project Management Job Type Full-Time
Description 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 1,300 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 CMC Technical Director is a key leadership position within an anticipated donor-funded program, responsible for the development and implementation of CMC and product supply technical assistance activities across multiple countries in Africa. As the Technical Director for this program, they will provide strategic technical oversight and direction to all implementation of activities related to the programs objective of increasing the supply and access of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, GMP, Dossier development and submission, business and commercialization planning), pharmaceutical sector planning/development, product development, and technology transfer. The Technical Director will lead a team of about 5-6 technical staff and consultants involved in the implementation of CMC-focused technical activities. They will also oversee the implementation of activities by external partners on this opportunity. Additionally, they act as a highly visible thought leader, interfacing with global experts, partners, regional stakeholders, and leaders in supply and manufacturing, and developing and disseminating new content to advance global knowledge on sustainably increasing the supply of essential medicines. 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 CMC Technical Director has the following responsibilities: Provide leadership for the management and implementation of CMC-related technical activities for a donor-funded project, in coordination with the Project Director. Provide technical and strategic leadership to technical experts (staff, consultants, manufacturers, and multiple consortium partners) in manufacturing (including GMP, Dossier development and submission, business and commercialization planning), pharmaceutical sector planning /development, product development, and technology transfer. Serve as key point of contact with the donor for technical engagements, offering expert advice and insights to advance the introduction of new and complex pharmaceutical products as directed by the Project Director. Define strategy and approach for technical assistance delivery across all areas related to the supply of essential medicines and manufacturing support, ensuring alignment with international best-practices and with already defined USP technical approaches, where relevant. Ensure consistent, high-quality, and results-driven technical assistance provision for all activities under their technical scope, identifying and delivering continuous improvements based on new evidence / information, and programmatic experience. Lead CMC work group, comprised of regional technical experts in CMC, market intelligence experts, and key partners, directed to help inform technical approach and continuous improvement. Work closely with donors to proactively identify and advise on opportunities to address supply concerns in HIV / AIDS, Malaria, MNCH, and other areas as directed. Actively participate in a cross-functional team to ensure the objectives of programs are successfully met. Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports. Oversee resource deployment for their area, with the objective of maximizing efficiency and impact and of progressively developing staff and local/ regional partners. Act as globally visible thought leader in area, actively advancing and deploying relevant knowledge based on programmatic experience and identified relevant research topics identified by donor externally in relevant forums. Interfaces regularly with key global external stakeholders/ groups in relevant areas including, with WHO pre-qualification team, Global Drug Facility, procuring agencies, and other key work groups. 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: Master's degree in pharmaceutical science, chemistry, engineering or science related field of study required; PhD strongly preferred. Extensive 12 + years experience leading and implementing technical assistance. programs in expanding access to global health products and pharmaceuticals. Substantive 8+ years people management experience and skills, including ability to seamlessly manage virtual teams. Substantive 8+ years Pharmaceutical sector experience including previous work experience with low-resource setting country manufacturers. Substantive regulatory filling experience including with but not limited to USFDA. Experience in formulation development for finished pharmaceutical products. Experience working or interacting with CDMOs. Understanding of global dynamics impacting the supply of quality-assured pharmaceuticals and medical products. Direct experience with or understanding of WHO pre-qualification process. Working understanding of Chemistry, Manufacturing and Controls and Good Manufacturing Practices. Demonstrated thought leadership in areas related to medical product access and supply. Strong written (especially technical writing) and oral communication skills. Willingness to travel at least 25% of the time. Additional Desired Preferences Work experience in LMICs, preferably in Africa. Fluency in French or Portuguese. Experience in at least one of the following health areas: HIV/ AIDS, malaria, AMR, MNCH. Supervisory Responsibilities Yes. This position will manage 3-4 direct reports, including technical staff based in Africa, and will also oversee and manage at least two external partners on a donor-funded opportunity. 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 $153,000.00 $203,500.00 annually. 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. 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. Job Category Technical Programs Job Type Full-Time
Description 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 1,300 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 This is a non-supervisory, technical position in USPs Analytical Development Laboratory (ADL). In this role, Scientist III is responsible for working on projects related to the research, evaluation, development, and validation of procedures that support USPs products and services. The developed procedures evaluate the identity, strength, and purity primarily of small molecule/biologic drug substances and products, dietary supplements, food ingredients, and excipients. The Scientist III has experience in analytical techniques, specifically in chromatography, and can troubleshoot, and provide input on routine projects, while collaboratively drawing conclusions about the results with the project team. The Scientist III is a hands-on role that requires most of the work in the laboratory. This is a full time position. 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 Scientist III, ADL has the following responsibilities: Laboratory work 80% Work independently, or with little guidance, to evaluate, develop, and validate chromatographic (i.e., HPLC, GC) procedures for the analysis of identification, assay, and organic impurities for small molecule/biologic drug substances and products, dietary supplements, food ingredients and excipients. Plan and implement experiments, provide input on/draw conclusions, and clearly communicate the results with the project team. Assess the submitted procedures based on the method verification work and support the review of the final draft of the procedure. Routinely apply personal experience, academic training, and insights to address technical problems. Collaborate in a team setting to achieve goals. Training, Cross-Collaboration, and Continuous Learning 20% Demonstrate a strong desire to continue learning, and proactively seek opportunities to grow personal capability. May participate and/or present at internal and external scientific/project meetings. May train staff in processes, techniques, and instrumentation. May recommend and implement creative approaches or processes to improve laboratory operations. 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 in a scientific field with seven (7) years of confirmed experience, or Masters degree in a scientific field with five (5) years of confirmed experience, or Ph. D. degree in a scientific field. Working knowledge, understanding, and hands-on experience with separation analyses such as liquid (HPLC, UPLC) and gas chromatography (GC), as well as other general chemistry principles and techniques. In limited circumstances, an equivalent combination of training or special scientific accomplishments is acceptable in lieu of the years of relevant experience. Additional Desired Preferences Knowledge and hands-on experience of small molecule/biologic/natural product analysis by spectroscopic techniques (IR, UV-Vis), LC-MS and/or GC-MS is a plus. Experience working in a fast-paced environment with multi-layered priorities. Flexible and concurrent management of multiple tasks. Experience working in the compendial, pharmaceutical, chemical and/or biotechnology industry. Experience working in GLP or ISO-17025 regulated laboratories is a plus. Experience working with Empower chromatography software and Electronic Laboratory Notebook Software is a plus. 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 $85,500.00 Mid.$111,250.00 annually. 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. 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. Job Category Chemistry & Scientific Standards Job Type Full-Time
Description 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 1,300 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 This is a hands-on, non-supervisory position working as a key member of the Reference Standards Production (RSP) team. The Production Quality Specialist plays a pivotal role in the production of USP Reference Standards (RS). The incumbent is responsible to prepare, review and issue required documentation and production instructions such as batch records, primary and secondary package labels, and change authorizations in accordance with company policies, quality systems. They are also responsible for providing real-time data to managers, generation of accurate reports, and rapid assessment of potential problems. The incumbent develops and manages systems and databases that are critical to the success of the department. The position is a critical component of USPs core business and is expected to proactively support quality improvement and maintain USPs culture of safety. 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 Associate Production Quality Specialist has the following responsibilities: Supports the creation, issuance, and retention of batch records, finished product labels and other documentation used in the production of all USP Reference Standards, in accordance with department SOPs and ISO 9001 guidelines. Manages label inventory, maintaining the accuracy and availability of printing supplies, through physical counts, inventory adjustments, and purchase requests, ensuring production demand is uninterrupted. Uses scientific judgement with Quality Assurance, Scientific, and Legal department staff to resolve discrepancies on documentation/labels and ensure that the labels created for use on USP Reference Standards meet all requirements and are error free. Develops and manages various department-level programs, including department forms review and revision, and tracking change control implementation, in a fast-paced team environment under constant deadline pressures. Monitors procedures of the entire production cycle to ensure they are efficient and comply with safety and quality standards, revising SOPs and department forms as needed and using scientific judgment where applicable. Independently prepares and distributes production performance reports. Maintains relevant production-related documentation repository in Oracle database and performs other transactions in support of production-related activities. Investigates technical issues and seeks out resources to resolve them; provides training and technical guidance on label printers. Demonstrates a commitment to safety and seeks opportunities to promote USPs culture of safety in the production environment. 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: Bachelor's degree in Natural Sciences (chemistry, biology, biochemistry) or related field with at least two (2) years of directly related experience, or an equivalent combination of training and experience. Understanding of ISO 9001 guidelines and quality systems. Readily learns new or specialty software applications. Highly organized, exceptional attention to detail, and a results-driven approach. Additional Desired Preferences Skilled at establishing effective working relationships in a diverse team setting for the purpose of accomplishing departmental goals. Ability to work independently and meet deadlines, yet understands when to escalate issues, especially in urgent or complex situations. Ability to handle multiple priorities in a fast-paced environment. Proven capability to productively support internal and external clients. Must be a team player. Conveys a professional image through their actions. USP experience and/or experience in the pharmaceutical industry a plus. Familiarity with scientific/technical terminology preferred. Analyzing information, reporting research results, promoting process improvement, safety management. Takes personal responsibility to ensure work is delivered on time and is of the highest quality. 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 $32.31 $41.03 per hour. 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. 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. Job Category Laboratory/Production Job Type Full-Time
Description
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 1,300 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
This is a professional individual contributor position that will be part of the Healthcare, Quality & Safety (HQS)
Center of Excellence under the Personalized Medicines group. This role will be responsible for leading the
development of future standards and solutions for Pharmacogenomics and Software as a Medical Device that
address the needs of healthcare professionals. This includes partnership and collaboration with USP Expert
Committees, external experts and cross-functional teams on exploring key topics such as pharmacogenomics,
digital medicine, SaMD and other emerging areas. The incumbent will lead critical evaluation of relevant
literature, scientific data and evidence and development of priority standards and solutions. This position will
collaborate with documentary scientists in the Healthcare Quality and Safety group, incorporating global
perspectives and helping to shape the engagement strategy pharmacogenomics and SaMD stakeholders and USP
solutions.
In addition, this position coordinates and facilitates the workplans related to the above with all relevant USPs
Expert Committees and healthcare practitioner input into USP standards-setting activities. This individual will
drive outreach to key stakeholders at key conferences and related events and coordinate development of key
stakeholder forums, workshops, roundtables and education to foster engagement and promote adoption of these
standards.
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 Senior Scientist I has the following responsibilities:
Works with the Director, Personalized Medicine to lead the development of research summaries, draft
standards, concept papers, stimuli articles, and other position papers on personalized medicines. Support the
establishment of USP Personalized Medicine Expert Committee and its subcommittees as important
convening bodies for the development of compendial standards that drive the adoption of pharmacogenomics,
digital therapeutics (e.g., SaMD) and personalized medicine in general.
Utilizing the USP case-based approach, lead the planning and organizing of the personalized medicines
standard setting activities of the four HQS expert committees (Personalized Medicine, Healthcare Information
& Technology, Healthcare Safety, Quality, and Nomenclature and Compounding). Develop a comprehensive
workplan for these activities in the cycle and beyond, spelling out the composition and types of
standard setting bodies (e.g. expert committees, subcommittees, Joint subcommittees, advisory panels, expert
panels, etc).
Advocate USPs position as a leading standard setting organization for personalized medicine by seeking out
and holding interactions with a diverse set of stakeholders. Identify opportunities for and lead on the
development and delivery of presentations and other deliverables to external stakeholders on current and
future USP personalized medicine standards. Represent USP in various personalized medicine stakeholder
interactions. Participates in the development and implementation of enhanced initiatives for stakeholder
engagements on draft and final standards such as open stakeholder forums, workshops, roundtable discussions
and other events.
Guide the systematic development of briefing materials for and lead in the scheduling of all expert volunteer
activities leading to the development of personalized medicines standards and related products. Lead and
manage the activities of expert volunteers for the personalized medicines expert committee, research fellows,
student interns and other temporary staff that USP may bring on to support these efforts.
Support the interface between HQS and cross-functional/global teams on USP personalized medicine
standards to ensure work integration and alignment with inter-departmental workplans. Identify opportunities
for and collaborate with cross-functional teams at USP in the development of implementation tools for
personalized medicines, such as education course development, verification programs and digital tools.
Secure services as needed from other departmental, divisional, and organizational groups.
Utilize internal and external resources to systematically collect and regularly compile relevant scientific
information and data pertaining to USP current and future personalized medicines standard setting activities,
and curate this information for dissemination via various USP communication channels such as website
updates, newsletters, outreach emails, etc.
Keeps abreast of and regularly update USP colleagues and relevant collaborators about current trends and
developments in personalized medicines especially application of new healthcare technologies,
pharmacogenomics, digital therapeutics and other emergent areas. Provide recommendations for potential
application and impact of these developments to personalized medicines activities at USP generally.
Liaise between USP and governmental inter-agency activities at international, federal and state level (e.g.
EMA, FDA, CDC, NABP) on personalized medicines areas of common interest to USP.
Drives global outreach to key USP regional teams and Global Health and Manufacturing Services department
to identify and engage with global stakeholder organizations. This includes presenting at international and national meetings and participating in relevant discussions. Provides assistance and guidance for standards
that can impact global health stakeholders.
Possesses understanding of compounding monographs, general chapters and various USP policy issues both
internally and externally including response to inquiries and stakeholder issues.
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:
Pharmacist with a doctoral degree in pharmacy, chemistry or pharmaceutics and 5 years (or MS and 7 years)
of relevant experience in compounding, personalized medicines, pharmacogenomics, digital therapeutics,
digital medicine, SaMD, or related field; alternatively pharmaceutical, biotechnology or life science industry
experience may be applicable. An equivalent combination of experience and education may be substituted
(e.g., RPh, MPH, MS in Nursing, Pharmacy or Healthcare related field).
Possesses knowledge of applicable Federal Food, Drug and Cosmetic laws, regulations, and/or codes as they
relate to personalized medicine. Possesses knowledge of the FDAs Drug Quality and Security Act of 2013,
FDA policy guidance on regulation of medical devices, pharmacogenetic tests and genetic tests for heritable
markers, submission of pharmacogenomic data for drug labels . click apply for full job details
