Director, CMC Technical

Job Description

Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world’s 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 minds—regardless of background—to 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 program’s 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, 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. 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: Program Specialist (Program/Project Management) PROGR002766 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 work—an 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 non-supervisory, position within Region, Program & Operations (RPO) that oversees marketing operational activities including program performance and planning process, project and budget management, and go-to-market initiatives that support growth goals and KPIs. Key responsibilities include cross-collaboration with industry programs, digital marketing and RPO analytics teams to coordinate projects with clear objectives, milestones, budgets and timelines. The associate program lead will effectively track, monitor and report on project schedules to marketing leadership team and other key stakeholders to drive successful completion. The incumbent will develop performance metrics and key indicators and facilitate quarterly meetings to drive department visibility and updates. This role is also responsible for coordinating marketing campaign planning and key external stakeholder meetings and events that are aligned with program outreach goals. The associate program lead will drive thought leadership and provide recommendations to team on project prioritization, process improvements, problem resolution, and best practices and methods to improve business outcomes. In addition, this role will foster great communication and work with internal and external partners to facilitate and drive all related activities to successfully deliver project goals. 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 Program Specialist – RPO Marketing Projects Will: Have proven experience in planning at the strategic and tactical level to develop and execute efforts in collaboration with the Marketing team: Drive cross-program quarterly business performance reviews to monitor delivery on SSP/KPI goals and facilitate department meetings and program updates with marketing leadership team. Support Digital Marketing team in developing and monitoring campaign planning, calendars and timelines including campaign go-live dates, asset approvals, and stakeholder feedback. Collaborate with Marketing leads on department and program budgets, facilitate contract and PO approvals (via docusign) and drive expense and PO tracking when needed. Work closely with USP approved global agencies, vendors, finance and legal teams to ensure compliance with company procurement, legal, and data privacy policies in support of key marketing campaigns, initiatives and events. Be adept at analyzing, preparing, and ensuring execution of responsibilities with minimal guidance and according to strict deadlines. Have ability to handle complexity, troubleshoot and interpret technical/science content to work across teams to communicate, develop and monitor plans. Identify, prioritize & manage internal/external meetings, conferences and events to support stakeholder engagement; develop & disseminate content that highlights insights from the events, when applicable. Have strong oral and written communication skills with ability to present key status updates and effectively summarize projects plans to leadership and cross-functional teams. Develops an overall understanding of USP’s business (Complex Generics, Small Molecules, Dietary Supplements and Herbal Medicines) to ensure appropriate dialogue and implementation of program support. 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 business, marketing and/or related field experience. Minimum of 4 - 5 years for the program manager, with at least 2-3 relevant experience, preferably in pharma or health care sector. The candidate should have good written and communication skills in the English language. Organized & results - oriented with strong time-management, attention to detail and problem-solving skills Proficient experience in using the Microsoft Office suite of products including Word, Excel, and PowerPoint, PowerPoint Designer with virtual presentation skills. The ability to influence without direct authority. Results driven with demonstrated successful outcomes. Ability and desire to work well with diverse employees in a cooperative and friendly manner. Ability to handle multiple priorities in a fast-paced environment. Additional Desired Preferences Experience using data analytical platforms (e.g. Tableau, Adobe Analytics, Adobe Creative Suite such as Illustrator and photoshop, etc.) Certified Project Management Professional (PMP)-PMI PMP or other project management certifications Excellent relationship-building skills with stakeholders. Self-motivated and able to work in a fast-paced multi-task environment. Superior interpersonal skills: professionalism, collaboration, accountability, delegation, and customer service. Ability to build effective work relationships quickly and work collaboratively in a global setting both internally and externally. High business acumen abilities - can understand and deliver on business objectives. High comfort with navigating through ambiguity and frequent change, and course-adjusting in the moment. Supervisory Responsibilities None Benefits USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected. Job Category Project Management Job Type Full-Time Show more Show less