Senior Manager CMC Technical Advisor

Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds leading health and science experts to develop rigorous quality standards for medicines dietary supplements and food ingredients. At USP we believe that scientific excellence is driven by a
commitment to fairness integrity and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1300 professionals across twenty global locations working to strengthen the supply of safe highquality 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 meritbased 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 Manager Chemical Manufacturing and Controls (CMC) Technical Advisor is a key technical leadership position within an anticipated donorfunded 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 programs objective of increasing the supply and access of qualityassured 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 he/ she acts 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 highquality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidencebased decisionmaking 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 highperforming inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and resultsdriven work environments.

The Senior Manager Chemical Manufacturing and Controls (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 bestpractices and with already defined USP technical approaches where relevant.
• Ensure consistent highquality and resultsdriven technical assistance provision for all activities under his/ her 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 crossfunctional 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 his/ her 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 prequalification 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:

• Masters 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 lowresource 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 qualityassured pharmaceuticals and medical products.
• Direct experience with or understanding of WHO prequalification 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

This position will manage 34 direct reports including technical staff based in Africa and will also oversee and manage at least two external partners on a donorfunded opportunity.

Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.
Compensation
Base Salary Range: USD $131500.00 $170500.00 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 jobrelated reasons.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Required Experience:

Senior Manager