Lead CMC Technical Advisor
Apply NowCompany: United States Pharmacopeia
Location: Rockville, MD 20850
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 Lead Chemical Manufacturing and Controls (CMC) Technical Advisor is a key technical leadership position within an anticipated donor-funded program. As the lead for this program for Product Supply and CMC, the incumbent provides 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. 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 Lead CMC Technical Advisor has the following responsibilities:
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.
Provide oversight for technical staff, regional / local partners, and consultants involved in delivery of manufacturing support, ensuring strong development trajectory for staff and regional / local partners.
Work closely with donor to proactively identify and advise on opportunities for addressing 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
Reports will scale with program growth and will include relevant technical staff serving non presence countries - with nature of reporting line (solid v. dotted) varying by location.
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 - $169,750.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
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.
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 Lead Chemical Manufacturing and Controls (CMC) Technical Advisor is a key technical leadership position within an anticipated donor-funded program. As the lead for this program for Product Supply and CMC, the incumbent provides 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. 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 Lead CMC Technical Advisor has the following responsibilities:
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.
Provide oversight for technical staff, regional / local partners, and consultants involved in delivery of manufacturing support, ensuring strong development trajectory for staff and regional / local partners.
Work closely with donor to proactively identify and advise on opportunities for addressing 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
Reports will scale with program growth and will include relevant technical staff serving non presence countries - with nature of reporting line (solid v. dotted) varying by location.
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 - $169,750.00 annually.
Target Annual Bonus: % Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons.
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.